documents

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)

659,070 rows where document_type = "Other" sorted by posted_date descending

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posted_year >30

agency_id >30

document_type 1

  • Other · 659,070 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
EPA-R09-OAR-2021-0864-0006 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Draft Permit for Cache Creek Casino Resort Other   2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z 2026-10-16T03:59:59Z 2026-09-16T02:56:08Z   1 0 09000064b956324a
EPA-R09-OAR-2021-0864-0005 EPA Part 71 Permit Application for Cache Creek Casino Resort EPA-R09-OAR-2021-0864 Draft Permit Docket Index - Cache Creek Other   2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T02:53:43Z   0 0 09000064b95632e5
FDA-2026-P-10739-0001 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 Suitability Petition from Senores Pharmaceuticals, Inc. Other Petition(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T15:27:02Z   1 0 09000064b9551619
FDA-2026-H-10568-0001 FDA DAB Civil Money Penalty; Akmal Inc. d/b/a Cloud 9 Smoke Shop FDA-2026-H-10568 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T20:52:57Z   0 0 09000064b9561586
FDA-2026-H-10576-0001 FDA DAB Civil Money Penalty; Knudson Management Inc., d/b/a Cenex / Wild Rice Depot FDA-2026-H-10576 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:55:30Z   0 0 09000064b956161f
FDA-2026-H-10578-0001 FDA DAB Civil Money Penalty; King Westchester Deli Grocery Inc., d/b/a King Westchester Deli Grocery FDA-2026-H-10578 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T18:54:09Z   0 0 09000064b955acc2
FDA-2026-P-10779-0001 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 Suitability Petition from Quagen Pharmaceuticals LLC Other Petition(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T21:31:01Z   1 0 09000064b954cdad
FDA-2026-H-10585-0001 FDA DAB Civil Money Penalty; Save Liquor LLC, d/b/a SAVE / Southside Express Convenience Store FDA-2026-H-10585 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T23:31:29Z   0 0 09000064b9563241
FDA-2026-H-10572-0001 FDA DAB Civil Money Penalty; Kernaghan's Service, Inc. d/b/a Kernaghans Pik & Pump / Conoco FDA-2026-H-10572 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:19:43Z   0 0 09000064b95616fe
FDA-2021-V-0331-0005 FDA Laser Light Show FDA-2021-V-0331 Variance Approval Letter from FDA CDRH to OSA International, INC Other Approval for Variance (VRA) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:57:18Z   0 0 09000064b955bc37
FDA-2026-P-10693-0002 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 Acknowledgement Letter from FDA DMB to Gilead Sciences, Inc. Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:44:45Z   0 0 09000064b9523abe
FDA-2026-H-10573-0001 FDA DAB Civil Money Penalty; The Magic Mushroom, LLC d/b/a The Magic Mushroom FDA-2026-H-10573 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:41:59Z   0 0 09000064b955ede1
FDA-2016-N-3120-0585 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Participation Other Public Participation 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:09:35Z   0 0 09000064b95549cd
FDA-2026-H-10581-0001 FDA DAB Civil Money Penalty; Smokers Choice 1 LLC, d/b/a Smoker’s Choice FDA-2026-H-10581 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:24:09Z   0 0 09000064b955acc8
FDA-2026-H-10575-0001 FDA DAB Civil Money Penalty; Gold Mini Mart Corp. d/b/a Gold Mini Mart FDA-2026-H-10575 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T20:41:55Z   0 0 09000064b9561078
FDA-2026-P-9802-0008 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 Amendment to Suitability Petition from Spencer Fane LLP Other Amendment 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T21:45:29Z   1 0 09000064b9561667
FDA-2023-V-0784-0004 FDA Laser Light Show FDA-2023-V-0784 Variance Renewal from Dawnpatrol LLC Other Application for Variance (VAR) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:26:36Z   0 0 09000064b9512871
FDA-2026-P-10739-0002 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 Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T15:27:07Z   0 0 09000064b955161c
FDA-2026-V-10397-0003 FDA Laser Light Show FDA-2026-V-10397 Variance Approval Letter from FDA CDRH to TMRW Sports Group, dba "TGL", "WTGL" Other Approval for Variance (VRA) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:28:58Z   0 0 09000064b955bc35
FDA-2026-P-10693-0001 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 Citizen Petition from Gilead Sciences, Inc. Other Citizen Petition 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:44:40Z   1 0 09000064b9523a58
FDA-2016-N-3120-0584 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Entry of Appearance Other Appearance Request 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:09:30Z   0 0 09000064b95549cb
FDA-2025-P-1807-0368 FDA Petition for Reclassification of Covid-19 mRNA And Adenoviral Vector Products as Gene Therapy Products and for Regulatory Action Regarding the Statutory Violations and International Legal Contraventions Inherent in the Covid-19 Countermeasures Program FDA-2025-P-1807 Response Letter Other Response(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:11:17Z   0 0 09000064b955ee1b
FDA-2024-V-2018-0005 FDA Laser Light Show FDA-2024-V-2018 Variance Renewal Approval Letter from FDA CDRH to Dorsal Entertainment LLC Other Approval for Variance (VRA) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:15:06Z   0 0 09000064b955bc27
FDA-2026-V-10397-0002 FDA Laser Light Show FDA-2026-V-10397 Acknowledgment Letter from FDA DMB to TMRW Sports Group, dba "TGL", "WTGL" Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:28:51Z   0 0 09000064b94d0682
FDA-2026-H-10570-0001 FDA DAB Civil Money Penalty; Hannibal Sandy’s, Inc. d/b/a BP / To Go FDA-2026-H-10570 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T18:16:47Z   0 0 09000064b955edfa
FDA-2026-H-10577-0001 FDA DAB Civil Money Penalty; Lake Life Petro LLC, d/b/a Jacksonville Marathon FDA-2026-H-10577 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T18:51:22Z   0 0 09000064b9557ee1
FDA-2026-H-10583-0001 FDA DAB Civil Money Penalty; Pic N Tote Two LLC, d/b/a Pic N Tote / VP Racing Fuels FDA-2026-H-10583 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:59:11Z   0 0 09000064b9561655
FDA-2024-P-1871-0015 FDA Requests the Commissioner to ensure that applications submitted under 505(j) and 505(b)(2) that rely on Lutathera include data necessary to show that a proposed product is pharmaceutically equivalent, bioequivalent, and can be expected to have the same clinical effect and safety profile as Lutathera when administered to patients under the conditions specified in the labeling FDA-2024-P-1871 Reconsideration Response Other Letter(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:17:41Z   0 0 09000064b9554926
FDA-2026-H-10571-0001 FDA DAB Civil Money Penalty; Mill Street Mart Inc. d/b/a Mill Street Mart Inc. FDA-2026-H-10571 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:23:31Z   0 0 09000064b955efc2
FDA-2026-H-10569-0001 FDA DAB Civil Money Penalty; Delicious Deli I Corp. d/b/a Catherine Deli & Bagels FDA-2026-H-10569 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:38:31Z   0 0 09000064b955aeac
FDA-2026-H-10579-0001 FDA DAB Civil Money Penalty; Eablad LLC, d/b/a Shell / Food Mart FDA-2026-H-10579 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:30:08Z   0 0 09000064b9560705
FDA-2024-V-2018-0004 FDA Laser Light Show FDA-2024-V-2018 Variance Renewal from Dorsal Entertainment LLC Other Application for Variance (VAR) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:14:46Z   0 0 09000064b955bc2c
FDA-2026-P-10785-0002 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 Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C. Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:12:00Z   0 0 09000064b9562c0d
FDA-2023-V-0784-0005 FDA Laser Light Show FDA-2023-V-0784 Variance Renewal Approval Letter from FDA CDRH to Dawnpatrol LLC Other Approval for Variance (VRA) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:26:58Z   0 0 09000064b955bc28
FDA-2026-H-10501-0001 FDA DAB Civil Money Penalty; Harry's Tobacco & Vape Outlet, Inc. d/b/a Harry's Tobacco & Vape Outlet FDA-2026-H-10501 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:01:08Z   0 0 09000064b955210d
FDA-2026-R-10632-0001 FDA DAB No Tobacco Sale Order; Central Park Grocery Corp. d/b/a Central Park Grocery FDA-2026-R-10632 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T20:46:42Z   0 0 09000064b9561580
FDA-2026-H-10496-0001 FDA DAB Civil Money Penalty; Jalaram United Inc. d/b/a Shell / Food Mart FDA-2026-H-10496 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T20:56:13Z   0 0 09000064b9562374
FDA-2026-V-10397-0001 FDA Laser Light Show FDA-2026-V-10397 Variance Application from TMRW Sports Group, dba "TGL", "WTGL" Other Application for Variance (VAR) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T17:28:39Z   0 0 09000064b94d05cb
FDA-2026-P-10779-0002 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 Acknowledgement Letter from FDA DMB to Quagen Pharmaceuticals LLC Other Acknowledgement Letter/Receipt 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T21:33:17Z   0 0 09000064b956165a
FDA-2026-H-10580-0001 FDA DAB Civil Money Penalty; Aisha LLC, d/b/a Coventry Mart FDA-2026-H-10580 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:31:43Z   0 0 09000064b955ac9f
FDA-2026-H-10574-0001 FDA DAB Civil Money Penalty; Steinway Gourmet Deli Inc. d/b/a Steinway Gourmet Deli FDA-2026-H-10574 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T18:03:27Z   0 0 09000064b955ede9
FDA-2026-H-10582-0001 FDA DAB Civil Money Penalty; Little General Store, Inc., d/b/a Little General 2225 / Marathon FDA-2026-H-10582 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:58:00Z   0 0 09000064b956163e
FDA-2026-H-9606-0001 FDA DAB Civil Money Penalty; Georgia Weigant d/b/a Run-A-Muck Mercantile FDA-2026-H-9606 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T19:26:41Z   0 0 09000064b955ac5c
FDA-2026-H-10567-0001 FDA DAB Civil Money Penalty; Donaciano Macareno and Candido Macareno d/b/a St. James Deli FDA-2026-H-10567 Complaint Other Complaint 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-15T23:29:59Z   0 0 09000064b956322f
FDA-2026-P-10785-0001 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 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:11:56Z   1 0 09000064b9562c0b
FDA-2026-P-8286-0003 FDA Request that the FDA determine whether DDAVP (desmopressin acetate) Nasal Spray, 0.01 mg/Spray (Needs No Refrigeration), Product No. 003 approved under New Drug Application (NDA) number 017922, held by Ferring Pharmaceuticals, Inc., has been voluntarily withdrawn for reasons of safety or effectiveness. FDA-2026-P-8286 Withdrawal Request from Hyman, Phelps & McNamara, P.C. Other Withdrawal 2026-09-15T04:00:00Z 2026 9 2026-09-15T04:00:00Z   2026-09-16T00:37:09Z   0 0 09000064b9560da6
FDA-2026-H-10497-0001 FDA DAB Civil Money Penalty; Santokh, Inc. d/b/a 7-Eleven 22684B FDA-2026-H-10497 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T20:56:23Z   0 0 09000064b95502a7
FDA-2026-H-10504-0001 FDA DAB Civil Money Penalty; Atlantic Truckstop LLC d/b/a Mobil / On The Move Convenience Stores FDA-2026-H-10504 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T23:45:32Z   0 0 09000064b955491e
FDA-2026-H-9670-0001 FDA DAB Civil Money Penalty; 460 W Enterprises, Inc. d/b/a Roosevelt Gourmet FDA-2026-H-9670 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T19:18:33Z   0 0 09000064b9550682
FDA-2026-H-10500-0001 FDA DAB Civil Money Penalty; Oka Tree Investment Corporation d/b/a New Oakes St. Market FDA-2026-H-10500 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T21:58:33Z   0 0 09000064b9550751
FDA-2026-H-9612-0001 FDA DAB Civil Money Penalty; Brilliant Management Inc. d/b/a Fast Trac FDA-2026-H-9612 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T23:33:45Z   0 0 09000064b955490f
FDA-2026-H-9605-0001 FDA DAB Civil Money Penalty; ZFK Quail LLC d/b/a Smoke N Gas FDA-2026-H-9605 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T19:14:02Z   0 0 09000064b95505cb
FDA-2026-H-9609-0001 FDA DAB Civil Money Penalty; Ralph Martinez Service, Inc. d/b/a Sunoco / Ultra Service Center FDA-2026-H-9609 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T21:42:17Z   0 0 09000064b954ffe6
FDA-2026-H-9608-0001 FDA DAB Civil Money Penalty; S M News & Grocery Inc. d/b/a S M News & Grocery FDA-2026-H-9608 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T21:43:18Z   0 0 09000064b95500de
FDA-2026-H-10498-0001 FDA DAB Civil Money Penalty; Krishiv Food Store LLC d/b/a Forest Food & Fuel / Marathon FDA-2026-H-10498 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T21:57:36Z   0 0 09000064b95505e9
FDA-2026-H-9613-0001 FDA DAB Civil Money Penalty; Smokestack Discount Tobacco, Inc. d/b/a Smoker Friendly Express Mart FDA-2026-H-9613 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T23:43:28Z   0 0 09000064b9554901
FDA-2026-H-9604-0001 FDA DAB Civil Money Penalty; Northlake BP Inc. d/b/a BP / To Go FDA-2026-H-9604 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T20:42:47Z   0 0 09000064b95502c2
FDA-2026-H-9610-0001 FDA DAB Civil Money Penalty; Smokies Tobacco Shop 4 LLC d/b/a Smokiez Shop FDA-2026-H-9610 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T21:41:28Z   0 0 09000064b954fd50
FDA-2026-H-9607-0001 FDA DAB Civil Money Penalty; JSST Enterprises LLC d/b/a Ultimate Vapor FDA-2026-H-9607 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T22:41:14Z   0 0 09000064b9551e71
FDA-2026-P-10741-0002 FDA Requests that the FDA require the sponsor of Trastuzumab to investigate whether the reported finding that approximately 68% of currently classified HER2-positive patients may not derive expected clinical benefit from trastuzumab is reproducible and to determine the extent and clinical significance of this finding. FDA-2026-P-10741 Acknowledgement Letter from FDA DMB to Quanticision Diagnostics, Inc. Other Acknowledgement Letter/Receipt 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-15T16:54:08Z   0 0 09000064b9551f9b
FDA-2026-H-9672-0001 FDA DAB Civil Money Penalty; Ohm Shree Hari LLC d/b/a Ritz Food Mart FDA-2026-H-9672 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T21:59:16Z   0 0 09000064b95507ef
FDA-2026-P-10740-0001 FDA Requests that the FDA declare that the drug product, Abiraterone Acetate Oral Suspension 500 mg/7.5 mL is suitable for submission in an Abbreviated New Drug Application. FDA-2026-P-10740 Suitability Petition from Pharmobedient Consulting, LLC Other Petition(s) 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T23:07:24Z   1 0 09000064b9551e5f
FDA-2026-P-10740-0002 FDA Requests that the FDA declare that the drug product, Abiraterone Acetate Oral Suspension 500 mg/7.5 mL is suitable for submission in an Abbreviated New Drug Application. FDA-2026-P-10740 Acknowledgement Letter from FDA DMB to Pharmobedient Consulting, LLC Other Acknowledgement Letter/Receipt 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T23:07:31Z   0 0 09000064b9551e62
FDA-2026-H-10502-0001 FDA DAB Civil Money Penalty; Concord Station, LLC d/b/a Concord General Store / Mobil FDA-2026-H-10502 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T22:39:09Z   0 0 09000064b9550473
FDA-2026-H-10503-0001 FDA DAB Civil Money Penalty; UP Hudson Gourmet Deli Grocery Corp. d/b/a UP Hudson Gourmet Deli & Grocery FDA-2026-H-10503 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T22:40:12Z   0 0 09000064b95518d3
FDA-2026-H-10499-0001 FDA DAB Civil Money Penalty; Mohammed & Jan GP d/b/a Smoke Plus FDA-2026-H-10499 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T22:45:23Z   0 0 09000064b9551fc4
FDA-2026-H-9671-0001 FDA DAB Civil Money Penalty; Yemsanali Grocery Inc. d/b/a Food Mart Superior Grocery FDA-2026-H-9671 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-14T19:11:40Z   0 0 09000064b954ff9a
FDA-2026-H-9674-0001 FDA DAB Civil Money Penalty; Ms Pearls Variety Shop LLC d/b/a Ms. Pearl's Variety Store FDA-2026-H-9674 Complaint Other Complaint 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-15T00:18:25Z   0 0 09000064b9550b08
FDA-2026-P-10741-0001 FDA Requests that the FDA require the sponsor of Trastuzumab to investigate whether the reported finding that approximately 68% of currently classified HER2-positive patients may not derive expected clinical benefit from trastuzumab is reproducible and to determine the extent and clinical significance of this finding. FDA-2026-P-10741 Citizen Petition from Quanticision Diagnostics, Inc. Other Citizen Petition 2026-09-14T04:00:00Z 2026 9 2026-09-14T04:00:00Z   2026-09-15T16:53:40Z   1 0 09000064b9551f99
FDA-2016-N-3120-0583 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Participation Other Public Participation 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T22:35:53Z   0 0 09000064b9522622
FDA-2026-P-2144-0007 FDA Requests that the FDA declare that the drug products Lamotrigine Tablets, 12.5 mg (unscored) and 75 mg (scored or unscored), are suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-2144 Approval Letter Other Approval 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:09:44Z   0 0 09000064b951f2c4
FDA-2026-P-10660-0001 FDA Requests that the FDA take administrative actions regarding drug products containing ethinylestradiol (also known as 17α-ethinylestradiol or EE2) and combined oral contraceptives that contain ethinylestradiol. FDA-2026-P-10660 Citizen Petition from Jacob Hassell Other Citizen Petition 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:33:51Z   1 0 09000064b9516ee4
FDA-2026-H-10465-0001 FDA DAB Civil Money Penalty; Love's Travel Stops and Country Stores, Inc. d/b/a Love's Travel Stop 429 FDA-2026-H-10465 Complaint Other Complaint 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:54:18Z   0 0 09000064b95173d8
FDA-2025-N-7130-0236 FDA Establishment Registration and Product Listing for Tobacco Products FDA-2025-N-7130 Request for Extension from RAI Services Company Other Request for Extension 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T23:38:28Z   0 0 09000064b951431e
FDA-2025-P-5305-0004 FDA Requests that the FDA Recognize self-knowledge, introspective awareness, and higher states of consciousness as legitimate areas of biomedical and neuroscientific inquiry relevant to mental health, cognitive function, and overall well-being FDA-2025-P-5305 Response Letter Other Denial of Petition 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T23:16:03Z   0 0 09000064b9520745
FDA-2026-N-9737-0001 FDA Notice of data availability and announcement of open public comment period: Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants - Nifedipine FDA-2026-N-9737 Notice of Data Availability and Announcement of Open Public Comment Period: Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants - Nifedipine Other Memorandum 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z 2026-10-13T03:59:59Z 2026-09-12T00:01:49Z   1 0 09000064b95239e4
FDA-2026-P-10660-0002 FDA Requests that the FDA take administrative actions regarding drug products containing ethinylestradiol (also known as 17α-ethinylestradiol or EE2) and combined oral contraceptives that contain ethinylestradiol. FDA-2026-P-10660 Acknowledgement Letter from FDA DMB to Jacob Hassell Other Acknowledgement Letter/Receipt 2026-09-11T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:33:55Z   0 0 09000064b951f2ad
FDA-2016-N-3120-0578 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Entry of Appearance Other Appearance Request 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T22:43:19Z   0 0 09000064b9511033
FDA-2026-V-9348-0002 FDA Laser Light Show FDA-2026-V-9348 Acknowledgment Letter from FDA DMB to Uplift DJ Entertainment Other Acknowledgement Letter/Receipt 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T19:32:19Z   0 0 09000064b945f9a6
FDA-2026-H-10470-0001 FDA DAB Civil Money Penalty; Altayyeb LLC d/b/a ZCloud Smoke Shop FDA-2026-H-10470 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:58:33Z   0 0 09000064b95173cf
FDA-2026-H-10471-0001 FDA DAB Civil Money Penalty; Alien Smoke & Vape Inc. d/b/a Alien Smoke & Vape FDA-2026-H-10471 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:59:22Z   0 0 09000064b951fb77
FDA-2026-H-10467-0001 FDA DAB Civil Money Penalty; Food Giant Supermarkets, Inc. d/b/a Food Giant FDA-2026-H-10467 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-11T00:19:36Z   0 0 09000064b9515b5b
FDA-2016-N-3120-0577 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Entry of Appearance Other Appearance Request 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T17:15:56Z   0 0 09000064b95092a8
FDA-2016-N-3120-0581 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Entry of Appearance Other Appearance Request 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T22:46:22Z   0 0 09000064b9513d93
FDA-2016-N-3120-0579 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Entry of Appearance Other Appearance Request 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T22:45:00Z   0 0 09000064b9513d92
FDA-2026-H-9679-0001 FDA DAB Civil Money Penatly; Wadah Fuel LLC d/b/a BP FDA-2026-H-9679 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-11T00:24:51Z   0 0 09000064b9516ede
FDA-2026-H-9681-0001 FDA DAB Civil Money Penalty; Yi’s, Inc. d/b/a Try Me Super Market FDA-2026-H-9681 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T23:05:17Z   0 0 09000064b9510cd5
FDA-2026-P-4112-0085 FDA Requests that the FDA take the following actions: 1. Rescind FDAs decision to file Ciplas section 505(b)(2) application for an apparent duplicate of DESCOVY; and 2. Refuse to grant Ciplas product an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant FDA-2026-P-4112 Final Response Letter Other Denial of Petition 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T23:08:05Z   0 0 09000064b9515d5b
FDA-2026-H-10462-0001 FDA DAB Civil Money Penalty; Zee Mart 2 LLC d/b/a Zee Mart FDA-2026-H-10462 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:15:01Z   0 0 09000064b950bbfb
FDA-2026-H-10464-0001 FDA DAB Civil Money Penalty; G. P. Northern Blvd. Service Center Inc. d/b/a Bolla Market FDA-2026-H-10464 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-11T04:00:00Z   2026-09-11T19:15:37Z   0 0 09000064b9514ca1
FDA-2026-H-9682-0001 FDA DAB Civil Money Penalty; South Windsor Gas Station Inc. d/b/a Cameron’s / Exxon FDA-2026-H-9682 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-11T00:12:39Z   0 0 09000064b9510f35
FDA-2026-H-10463-0001 FDA DAB Civil Money Penalty; Big Wills Deli LLC d/b/a Big Wills Deli & Convience Store FDA-2026-H-10463 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-11T00:15:15Z   0 0 09000064b9516751
FDA-2022-N-2390-0867 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Order Other Order 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T23:51:50Z   0 0 09000064b9515c83
FDA-2026-V-9348-0001 FDA Laser Light Show FDA-2026-V-9348 Variance Application from Uplift DJ Entertainment Other Application for Variance (VAR) 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T19:32:04Z   0 0 09000064b945f9a4
FDA-2016-N-3120-0576 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Notice of Entry of Appearance Other Appearance Request 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T15:33:22Z   0 0 09000064b94cb9cd
FDA-2026-P-10528-0002 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Acknowledgement Letter from FDA DMB to Marshall R. Shannon Other Acknowledgement Letter/Receipt 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T20:01:09Z   0 0 09000064b94d0869
FDA-2026-H-10466-0001 FDA DAB Civil Money Penalty; Sylvias of Polonia LLC d/b/a Sylvia's Bar FDA-2026-H-10466 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-11T00:21:33Z   0 0 09000064b9515b94
FDA-2026-H-9678-0001 FDA DAB Civil Money Penalty; Lyman’s on the Lake, Inc. d/b/a Lyman’s on the Lake FDA-2026-H-9678 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-11T00:23:18Z   0 0 09000064b9515c85
FDA-2026-H-10468-0001 FDA DAB Civil Money Penalty; So Fresh Enterprise, Inc. d/b/a So Fresh Supermarket FDA-2026-H-10468 Complaint Other Complaint 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-11T00:13:53Z   0 0 09000064b9515d33
FDA-2026-P-10528-0001 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Citizen Petition from Marshall R. Shannon Other Citizen Petition 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T19:51:15Z   1 0 09000064b94d0868

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    docket_id TEXT REFERENCES dockets(id),
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CREATE INDEX idx_docs_type ON documents(document_type);
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;