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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

20,242 rows where document_type = "Supporting & Related Material" and posted_year = 2026 sorted by posted_date descending

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agency_id >30

  • EPA 15,727
  • FDA 3,398
  • FWS 599
  • FAA 111
  • FMCSA 70
  • APHIS 63
  • PHMSA 42
  • ED 35
  • NOAA 33
  • USCG 32
  • NCUA 23
  • OSHA 15
  • NRC 14
  • NHTSA 11
  • CNCS 8
  • OCC 8
  • FSIS 6
  • VA 6
  • DEA 5
  • AMS 3
  • EBSA 3
  • FNS 3
  • HUD 3
  • NRCS 3
  • BLM 2
  • BOEM 2
  • FS 2
  • FSA 2
  • FTC 2
  • GSA 2
  • …

posted_year 1

  • 2026 · 20,242 ✖

document_type 1

  • Supporting & Related Material · 20,242 ✖
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
APHIS-2024-0040-0008 APHIS Availability of an Environmental Assessment for release of Aceria salsolae for biological control of Russian thistle APHIS-2024-0040 Decision and Finding of No Significant Impact for the Field Release of Aceria salsolae (Acari: Eriophyidae), a Mite for Biological Control of Russian Thistle (Salsola tragus), in the Contiguous United States August 2025 Supporting & Related Material Finding of no Significant Impact 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:13:17Z   0 0 09000064b94ba852
APHIS-2024-0040-0007 APHIS Availability of an Environmental Assessment for release of Aceria salsolae for biological control of Russian thistle APHIS-2024-0040 Field Release of Aceria salsolae (Acari: Eriophyidae), a Mite for Biological Control of Russian Thistle (Salsola tragus), in the Contiguous United States Environmental Assessment August 2025 Supporting & Related Material Environmental Assessment 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:13:13Z   0 0 09000064b94ba853
EPA-R09-OAR-2021-0864-0002 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Section 1 - Application Supporting & Related Material   2026-09-15T04:00:00Z 2026 9     2026-09-16T02:48:45Z   0 0 09000064b956326f
EPA-R09-OAR-2021-0864-0003 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Section 2 - Draft Permit and Related Documents Supporting & Related Material   2026-09-15T04:00:00Z 2026 9     2026-09-16T02:48:52Z   0 0 09000064b95632a4
EPA-HQ-OLEM-2022-0903-0667 EPA Alabama Coal Combustion Residuals Permit Program EPA-HQ-OLEM-2022-0903 Transcript from the Alabama CCR permit program proposed approval public hearing. September 3, 2026 Supporting & Related Material Transcript 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:56:20Z   0 0 09000064b9551fb6
EPA-R09-OAR-2021-0864-0004 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Section 3 - Supporting Documents Supporting & Related Material   2026-09-15T04:00:00Z 2026 9     2026-09-16T02:49:03Z   0 0 09000064b95632a6
FDA-2026-P-10693-0064 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 51 - Product Monograph for VEMLIDY Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:12Z   0 0 09000064b95243f1
FDA-2026-P-10693-0067 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 54 - Jones - The CryoEM Method MicroED as a Powerful Tool for Small Molecule Structure Determination Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:23Z   0 0 09000064b95243f4
FDA-2026-P-10693-0079 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 66 - FDA Petition Response to Katherine M Sanzo Lawrence S Ganslaw - Morgan Lewis Bockius et al Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:13Z   0 0 09000064b9524432
FDA-2026-P-10693-0084 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 71 - Orange Book Product Details for NDA 018877 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:37Z   0 0 09000064b9524487
FDA-2026-P-10693-0090 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 77 - LEVOXYL Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:59Z   0 0 09000064b952448d
FDA-2026-P-10693-0008 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 4 - Lengauer 2020 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:33Z   0 0 09000064b95244bc
FDA-2026-P-10693-0016 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 03 - FDA - Approval Letter for VEMLIDY Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:18Z   0 0 09000064b951d4ff
FDA-2026-P-10693-0018 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 05 - Exclusivity Summary for VEMLIDY - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:26Z   0 0 09000064b9522501
FDA-2026-P-10693-0019 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 06 - Wang - On the Single-Crystal Structure of Tenofovir Alafenamide Mono-Fumarate Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:31Z   0 0 09000064b9522502
FDA-2026-P-10693-0039 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 26 - Drugs at FDA - DESCOVY and VEMLIDY Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:01Z   0 0 09000064b9524324
FDA-2026-P-10693-0058 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 45 - Zumdahl - Chemistry Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:35Z   0 0 09000064b95243b9
FDA-2026-P-10785-0003 FDA Requests that the FDA declare that the drug products Famotidine Capsules, 20 mg and 40 mg, are suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-10785 Attachment 1 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:12:04Z   0 0 09000064b9560709
FDA-2026-P-10739-0004 FDA Request that the FDA declare that the drug product, Mirtazapine Tablet 5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10739 Attachment 2-RLD Package Insert Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T15:27:15Z   0 0 09000064b954f70c
FDA-2026-P-10693-0023 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 10 - July 29 Notice Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:47Z   0 0 09000064b95242d8
FDA-2026-P-10693-0031 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 18 - FDA - Petition Response to Gary Veron on Behalf of Mutual Pharm Co Inc Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:29Z   0 0 09000064b952431c
FDA-2026-P-10693-0032 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 19 - 67 Fed Reg 66593 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:33Z   0 0 09000064b952431d
FDA-2026-P-10693-0033 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 20 - DESCOVY Container Label Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:37Z   0 0 09000064b952431e
FDA-2026-P-10693-0036 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 23 - TEKTURNA Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:49Z   0 0 09000064b9524321
FDA-2026-P-10693-0038 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 25 - Orange Book 46th ed - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:58Z   0 0 09000064b9524323
FDA-2026-P-10693-0042 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 29 - Draft Guidance - Ematricitabine TAF Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:15Z   0 0 09000064b9524377
FDA-2026-P-10693-0056 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 43 - USAN Council - Statement on Aliskiren Fumarate Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:27Z   0 0 09000064b95243b7
FDA-2026-P-10693-0072 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 59 - Meet Yale Maestro of MicroED Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:47Z   0 0 09000064b952442b
FDA-2026-P-10693-0075 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 62 - Final Brief for Federal Defendants-Appellees Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:59Z   0 0 09000064b952442e
FDA-2026-P-10693-0082 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 69 - Amarin Pharma Inc v Apotex Inc Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:24Z   0 0 09000064b9524485
FDA-2026-P-10693-0083 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 70 - Orange Book Product Details for NDA 018832 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:28Z   0 0 09000064b9524486
FDA-2026-P-10693-0005 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 2 part 1- XtalPi Report Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:21Z   0 0 09000064b95244b9
FDA-2026-P-10779-0004 FDA Requests that the FDA determine and declare that Propylthiouracil Tablets, 100 mg and 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10779 Attachment 1 - Current Orange Book Details for RLD and Others Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:33:26Z   0 0 09000064b9562c09
FDA-2026-P-10785-0006 FDA Requests that the FDA declare that the drug products Famotidine Capsules, 20 mg and 40 mg, are suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-10785 Attachment 4 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:12:12Z   0 0 09000064b9560858
FDA-2026-P-10693-0015 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 02 - DESCOVY Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:13Z   0 0 09000064b951d4fe
FDA-2026-P-10693-0017 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 04 - VEMLIDY Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:22Z   0 0 09000064b9522500
FDA-2026-P-10693-0020 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 07 - Lengauer - Co-crystals Salts or Mixtures of Both Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:35Z   0 0 09000064b9522503
FDA-2026-P-10693-0022 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 09 - July 16 Notice Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:43Z   0 0 09000064b95242d7
FDA-2026-P-10693-0028 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 15 - FDA Petition Response to David Platt MD - Novartis Pharmaceuticals Corp Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:07Z   0 0 09000064b95242dd
FDA-2026-P-10693-0043 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 30 - Draft Guidance - Tenofovir Alafenamide Fumarate Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:19Z   0 0 09000064b9524378
FDA-2026-P-10693-0046 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 33 - CDER Product Quality Review Quality Assessment for NDA 209299 TAVALISSE - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:31Z   0 0 09000064b952437b
FDA-2026-P-10693-0047 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 34 - CDER Pharmacology Review for NDA 207561 GENVOYA - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:35Z   0 0 09000064b952437c
FDA-2026-P-10693-0052 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 39 - USAN Council - Statement of a Nonproprietary Name Adopted - TAM Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:11Z   0 0 09000064b95243b3
FDA-2026-P-10693-0062 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 49 - CONFIDENTIAL DESCOVY NDA - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:55Z   0 0 09000064b95243ef
FDA-2026-P-10693-0069 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 56 - Kuballa Liquid Nuclear Magnetic Resonance Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:33Z   0 0 09000064b95243f6
FDA-2026-P-10693-0070 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 57 - Guidance - ANDAs Pharmaceutical Solid Polymorphism Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:38Z   0 0 09000064b95243f7
FDA-2026-P-10693-0074 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 61 - Mooney - Nitrogen Magnetic Resonance Spectroscopy Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:55Z   0 0 09000064b952442d
FDA-2026-P-10693-0089 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 76 - NOVOTHYROX Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:55Z   0 0 09000064b952448c
FDA-2026-P-10693-0004 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 1 - Mercado CV Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:15Z   0 0 09000064b95244b8
FDA-2026-P-10693-0013 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 9 - Wang 2020 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:53Z   0 0 09000064b9525939
FDA-2026-P-10785-0004 FDA Requests that the FDA declare that the drug products Famotidine Capsules, 20 mg and 40 mg, are suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-10785 Attachment 2 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-16T00:12:06Z   0 0 09000064b956070a
FDA-2026-P-10779-0003 FDA Requests that the FDA determine and declare that Propylthiouracil Tablets, 100 mg and 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10779 Table of Contents Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:33:23Z   0 0 09000064b955efca
FDA-2026-P-10779-0005 FDA Requests that the FDA determine and declare that Propylthiouracil Tablets, 100 mg and 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10779 Attachment 2 - RLD Labeling Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:33:29Z   0 0 09000064b9562c0a
FDA-2026-P-10693-0025 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 12 - Draft Guidance - Determining Whether to Submit an ANDA Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:55Z   0 0 09000064b95242da
FDA-2026-P-10693-0026 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 13 - Draft Guidance - Applications Covered by Section 505 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:59Z   0 0 09000064b95242db
FDA-2026-P-10693-0029 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 16 - Guidance - Regulatory Classification of Pharmaceutical Co-Crystals Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:20Z   0 0 09000064b95242de
FDA-2026-P-10693-0037 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 24 - TEKTURNA Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:53Z   0 0 09000064b9524322
FDA-2026-P-10693-0045 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 32 - CDER Chemistry Review for NDA 208215 DESCOVY - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:27Z   0 0 09000064b952437a
FDA-2026-P-10693-0054 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 41 - WHO Guidance - Use of INNs Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:19Z   0 0 09000064b95243b5
FDA-2026-P-10693-0057 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 44 - Novartis Pharmaceuticals Corporation v Becerra Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:31Z   0 0 09000064b95243b8
FDA-2026-P-10693-0059 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 46 - Cruz-Cabeza - The Role of Solvation in Proton Transfer Reactions Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:39Z   0 0 09000064b95243ba
FDA-2026-P-10693-0066 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 53 - Newman From Powders to Single Crystals Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:19Z   0 0 09000064b95243f3
FDA-2026-P-10693-0078 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 65 - FDA Petition Response to Scott H Korn MD FACP - Merck Sharpe Dohme Corp Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:09Z   0 0 09000064b9524431
FDA-2026-P-10693-0081 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 68 - Draft Guidance - Safety Labeling Changes Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:20Z   0 0 09000064b9524484
FDA-2026-P-10693-0091 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 78 - Guidance - Evaluation of Therapeutic Equivalence Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:52:03Z   0 0 09000064b95244b6
FDA-2026-P-10693-0012 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 8 - Clabbers 2022 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:49Z   0 0 09000064b9525938
FDA-2026-P-10693-0014 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 01 - FDA - Approval Letter for DESCOVY Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:10Z   0 0 09000064b951d4fd
FDA-2026-P-10693-0024 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 11 - Guidance - Determining Whether to Submit an ANDA Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:51Z   0 0 09000064b95242d9
FDA-2026-P-10693-0030 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 17 - 54 Fed Reg 28872 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:25Z   0 0 09000064b95242df
FDA-2026-P-10693-0034 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 21 - VEMLIDY Container Label Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:41Z   0 0 09000064b952431f
FDA-2026-P-10693-0044 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 31 - Draft Guidance - Daclatasvir Dihydrochloride Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:24Z   0 0 09000064b9524379
FDA-2026-P-10693-0048 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 35 - CONFIDENTIAL Letter from FDA to Gilead Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:42Z   0 0 09000064b952437d
FDA-2026-P-10693-0051 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 38 - Draft Guidance - Sameness Evaluation in ANDA Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:06Z   0 0 09000064b95243b2
FDA-2026-P-10693-0053 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 40 - AMA US Adopted Names Naming Guidelines Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:15Z   0 0 09000064b95243b4
FDA-2026-P-10693-0055 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 42 - Orange Book 28th Ed - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:23Z   0 0 09000064b95243b6
FDA-2026-P-10693-0061 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 48 - CONFIDENTIAL GENVOYA NDA - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:51Z   0 0 09000064b95243ee
FDA-2026-P-10693-0068 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 55 - Reif Solid-state NMR spectroscopy Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:27Z   0 0 09000064b95243f5
FDA-2026-P-10693-0076 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 63 - FDA Petition Response to Thomas A Hayes MD - Bristol-Myers Squibb Co Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:03Z   0 0 09000064b952442f
FDA-2026-P-10693-0077 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 64 - 41 Fed Reg 51085 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:06Z   0 0 09000064b9524430
FDA-2026-P-10693-0085 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 72 - Supplement Approval Letter for NDA 018832 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:41Z   0 0 09000064b9524488
FDA-2026-P-10693-0088 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 75 - LEVO-T Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:51Z   0 0 09000064b952448b
FDA-2026-P-10693-0007 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 3 - Bruhn 2021 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:29Z   0 0 09000064b95244bb
FDA-2026-P-10693-0009 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Appendix 1 Exhibit 5 - Nakai 2025 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:45:37Z   0 0 09000064b95244bd
FDA-2026-P-10739-0003 FDA Request that the FDA declare that the drug product, Mirtazapine Tablet 5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10739 Attachment 1-Orange book Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T15:27:12Z   0 0 09000064b954f6bf
FDA-2026-P-10739-0005 FDA Request that the FDA declare that the drug product, Mirtazapine Tablet 5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) FDA-2026-P-10739 Attachment 3-Draft Package Insert Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T15:27:18Z   0 0 09000064b954f70d
FDA-2026-P-10693-0021 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 08 - Cheng - Tenofovir Alafenamide Fumarate Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:46:39Z   0 0 09000064b95242d6
FDA-2026-P-10693-0027 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 14 - 68 Fed Reg 36676 Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:03Z   0 0 09000064b95242dc
FDA-2026-P-10693-0035 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 22 - Guidance - Naming of Drug Products Containing Salt Drug Substances Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:47:45Z   0 0 09000064b9524320
FDA-2026-P-10693-0040 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 27 - Drugs at FDA - FAQs Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:06Z   0 0 09000064b9524325
FDA-2026-P-10693-0041 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 28 - Drugs at FDA - TEKTURNA Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:11Z   0 0 09000064b9524376
FDA-2026-P-10693-0049 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 36 - ODOMZO Prescribing Label Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:48:58Z   0 0 09000064b952437e
FDA-2026-P-10693-0050 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 37 - European Medicines Agency Assessment Report Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:02Z   0 0 09000064b952437f
FDA-2026-P-10693-0060 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 47 - Klein - Organic Chemistry - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:45Z   0 0 09000064b95243bb
FDA-2026-P-10693-0063 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 50 - CONFIDENTIAL CMC Amendment Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:49:59Z   0 0 09000064b95243f0
FDA-2026-P-9802-0009 FDA Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Dabrafenib Capsules, 100 mg strength FDA-2026-P-9802 Attachment 1 - Proposed labeling Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T21:45:46Z   0 0 09000064b956167e
FDA-2026-P-10693-0065 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 52 - European Medicines Agency - Assessment Report for VEMLIDY - Excerpt Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:15Z   0 0 09000064b95243f2
FDA-2026-P-10693-0071 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 58 - Nakai - Detection of Hydrogen Atoms Using Only 3D ED MicroED Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:42Z   0 0 09000064b952442a
FDA-2026-P-10693-0073 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 60 - Cambridge English Dictionary - SUBSTANTIAL Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:50:51Z   0 0 09000064b952442c
FDA-2026-P-10693-0080 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 67 - FDA - Paragraph IV Patent Certifications Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:16Z   0 0 09000064b9524433
FDA-2026-P-10693-0086 FDA Requests that the FDA rescind their decision to file Zydus’s section 505(b)(2) applications for apparent duplicates of DESCOVY and VEMLIDY and refuse to grant either of Zydus’s products an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant. FDA-2026-P-10693 Exhibit 73 - ALLOPURINOL Prescribing Information Supporting & Related Material Background Material 2026-09-15T04:00:00Z 2026 9     2026-09-15T17:51:44Z   0 0 09000064b9524489

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    docket_id TEXT REFERENCES dockets(id),
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CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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