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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)

584 rows where docket_id = "FDA-2016-N-3120" sorted by posted_date descending

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posted_year 6

  • 2017 483
  • 2021 50
  • 2026 32
  • 2016 10
  • 2018 7
  • 2019 2

document_type 3

  • Supporting & Related Material 526
  • Other 56
  • Notice 2

agency_id 1

  • FDA 584
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2016-N-3120-0588 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Joint Statement on Proposed Hearing Dates Other Statement 2026-10-08T04:00:00Z 2026 10 2026-10-08T04:00:00Z   2026-10-09T00:55:05Z   0 0 09000064b9653e97
FDA-2016-N-3120-0589 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Order Scheduling Hearing Other Order 2026-10-08T04:00:00Z 2026 10 2026-10-08T04:00:00Z   2026-10-09T00:55:11Z   0 0 09000064b9653f5d
FDA-2016-N-3120-0586 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 Appearance Other Appearance Request 2026-09-28T04:00:00Z 2026 9 2026-09-28T04:00:00Z   2026-09-28T19:40:28Z   0 0 09000064b95d4266
FDA-2016-N-3120-0587 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Order Summarizing Prehearing Conference and Order Granting 90-Day Extension Other Order 2026-09-28T04:00:00Z 2026 9 2026-09-28T04:00:00Z   2026-09-28T22:54:46Z   0 0 09000064b95e0d58
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   2026-09-24T18:45:10Z   0 0 09000064b95549cd
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-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-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-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-3120-0579 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-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-3120-0576 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-2016-N-3120-0582 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   2026-09-10T22:49:25Z   0 0 09000064b95110b9
FDA-2016-N-3120-0580 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   2026-09-10T22:45:35Z   0 0 09000064b95134a7
FDA-2016-N-3120-0575 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 2026-09-08T04:00:00Z 2026 9 2026-09-08T04:00:00Z   2026-09-08T22:06:57Z   0 0 09000064b94fa7bb
FDA-2016-N-3120-0574 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 2026-09-04T04:00:00Z 2026 9 2026-09-04T04:00:00Z   2026-09-04T17:54:56Z   0 0 09000064b94c37a3
FDA-2016-N-3120-0573 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 2026-09-03T04:00:00Z 2026 9 2026-09-03T04:00:00Z   2026-09-10T20:51:09Z   0 0 09000064b94c5305
FDA-2016-N-3120-0570 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets Notice Withdrawal 2026-08-13T04:00:00Z 2026 8 2026-08-13T04:00:00Z 2026-10-14T03:59:59Z 2026-10-14T09:00:39Z 2026-16536 0 0 09000064b943bc08
FDA-2016-N-3120-0572 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 1 - U.S. Department of Health and Human Services, Departmental Appeals Board, Civil Remedies Division, Kremers Urban Pharmaceuticals, Inc. Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended Release Methylphenidate Tablets, Case Development Order [Civil Remedies Division Procedures, March 28, 2016], August 13, 2026. Supporting & Related Material Background Material 2026-08-13T04:00:00Z 2026 8     2026-08-25T19:18:02Z   0 0 09000064b943af66
FDA-2016-N-3120-0569 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Methyl SOF (ANDA 091695) 022726 Other Memorandum 2026-03-02T05:00:00Z 2026 3 2026-03-02T05:00:00Z   2026-03-02T17:14:36Z   0 0 09000064b91e2ceb
FDA-2016-N-3120-0567 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 5_Kremers Hearing Request_2016-N-3120_CDER analysis Other Additional Information 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:27:22Z   0 0 09000064b91d86ba
FDA-2016-N-3120-0566 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 4_Kremers Hearing Request_2016-N-3120_CDER 12.85 statement Other Additional Information 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:26:54Z   0 0 09000064b91d86b8
FDA-2016-N-3120-0561 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 1d_Jan 2020 APSARD mtg_prsnt-Gomeni 20200118 Other Presentation 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:26:16Z   0 0 09000064b91d86ae
FDA-2016-N-3120-0564 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2a_Kremers_Dkt FDA-2016-N-3120_09 11 25_enclosure Other Memorandum 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:26:41Z   0 0 09000064b91d86b4
FDA-2016-N-3120-0559 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 1b_Jan 2020 APSARD mtg_prsnt-Babiskin 20200118 Other Presentation 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:25:58Z   0 0 09000064b91d8096
FDA-2016-N-3120-0558 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 1a_data description_PK updated_and noting withholding Other Letter(s) 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:25:48Z   0 0 09000064b91d8094
FDA-2016-N-3120-0557 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 1_Kremers_Dkt FDA-2016-N-3120_11 29 21 Other Letter(s) 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:25:36Z   0 0 09000064b91d8092
FDA-2016-N-3120-0563 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2_Kremers_Dkt FDA-2016-N-3120_09 11 25 Other Letter(s) 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:26:33Z   0 0 09000064b91d86b2
FDA-2016-N-3120-0565 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 3_Methylphenidate SOF (ANDA 091695) 021226 Other Letter(s) 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:26:47Z   0 0 09000064b91d86b6
FDA-2016-N-3120-0568 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 6_Kremers Hearing Request_2016-N-3120_draft proposed order Other Additional Information 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:27:31Z   0 0 09000064b91d86bc
FDA-2016-N-3120-0560 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 1c_Jan 2020 APSARD mtg_prsnt-AChildress 20200115 Other Presentation 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:26:08Z   0 0 09000064b91d8098
FDA-2016-N-3120-0562 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 1e_Jan 2020 APSARD mtg_prsnt-Spencer 20200118 Other Additional Information 2026-02-25T05:00:00Z 2026 2 2026-02-25T05:00:00Z   2026-02-25T20:26:25Z   0 0 09000064b91d86b0
FDA-2016-N-3120-0549 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 A091695N000Min-2_Redacted Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:47:25Z   0 0 0900006484a5f6c8
FDA-2016-N-3120-0545 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 091695 Kremers Advice Letter EU Dat Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:41:52Z   0 0 0900006484a5f69f
FDA-2016-N-3120-0547 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2015-9-22_Kremers Methylphenidate HCl ER Tablets-ANDA 091695 Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:43:39Z   0 0 0900006484a5f6c4
FDA-2016-N-3120-0551 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 data description Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:49:25Z   0 0 0900006484a5f6ca
FDA-2016-N-3120-0532 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0044_m1_Gen Corres_Summary Slides Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:01:14Z   0 0 0900006484a5f5f1
FDA-2016-N-3120-0533 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0048_m1_Gen Corres_Mtg Minutes_July Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:02:40Z   0 0 0900006484a5f5f2
FDA-2016-N-3120-0539 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2015-5-05_91695 MR denied Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:34:10Z   0 0 0900006484a5f5f8
FDA-2016-N-3120-0546 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2016-10-17 091695 Kremers Advice Letter (2) Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:42:57Z   0 0 0900006484a5f6a1
FDA-2016-N-3120-0531 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0044_m1_Gen Corres_Mtg Agenda Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:59:02Z   0 0 0900006484a5f5f0
FDA-2016-N-3120-0515 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m5_study r10-0827_case report forms Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:40:34Z   0 0 0900006484a5cf70
FDA-2016-N-3120-0518 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m5_study r10-0828_CSR Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:43:47Z   0 0 0900006484a5cf75
FDA-2016-N-3120-0536 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2014-11-12_ANDA 091695 Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:07:47Z   0 0 0900006484a5f5f7
FDA-2016-N-3120-0529 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0043_m1_correction of conv error Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:57:16Z   0 0 0900006484a5cfbb
FDA-2016-N-3120-0552 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Full Protocol Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:50:45Z   0 0 0900006484a5f6cb
FDA-2016-N-3120-0554 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 LCMS_ValidationReport_Methylphenidate_DBS_10uL Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:53:40Z   0 0 0900006484a5f6fe
FDA-2016-N-3120-0543 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2015-9-9_091695 7-20-15 Meeting Minutes Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:40:10Z   0 0 0900006484a5f69d
FDA-2016-N-3120-0524 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_M1_ba be studies_req for mtg Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:50:50Z   0 0 0900006484a5cfa2
FDA-2016-N-3120-0514 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m5_r10-0828_csr Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:39:40Z   0 0 0900006484a5cf68
FDA-2016-N-3120-0519 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0034_Response to Information Request Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:44:51Z   0 0 0900006484a5cf76
FDA-2016-N-3120-0521 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0038_m1_General Correspondence Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:46:57Z   0 0 0900006484a5cf8b
FDA-2016-N-3120-0553 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 LCMS_ValidationReport_Methylphenidate_DBS_5uL Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:52:38Z   0 0 0900006484a5f6f9
FDA-2016-N-3120-0556 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 RE_ ANDA 91695 Methylphenidate ER Tablets Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:55:26Z   0 0 0900006484a5f71d
FDA-2016-N-3120-0525 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_M2_summary of be studies Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:51:49Z   0 0 0900006484a5cfa3
FDA-2016-N-3120-0534 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2014-5-2_correspondence_20dec2013-email Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:06:14Z   0 0 0900006484a5f5f5
FDA-2016-N-3120-0544 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2015-9-9_A091695N000Min Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:41:01Z   0 0 0900006484a5f69e
FDA-2016-N-3120-0528 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_m5_csr Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:56:11Z   0 0 0900006484a5cfb9
FDA-2016-N-3120-0548 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 91695 - 11-13-2014 Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:46:30Z   0 0 0900006484a5f6c5
FDA-2016-N-3120-0526 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_m5_2015-3768 and 3769 -be_case report forms Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:53:09Z   0 0 0900006484a5cfa8
FDA-2016-N-3120-0527 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_m5_2015-3769-ba Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:54:42Z   0 0 0900006484a5cfaa
FDA-2016-N-3120-0517 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m5_study r10-0828_case report forms Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:43:00Z   0 0 0900006484a5cf74
FDA-2016-N-3120-0541 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2015-5-11_da-ku-correspondence-11may2015 Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:37:02Z   0 0 0900006484a5f69a
FDA-2016-N-3120-0516 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m5_study r10-0827_CSR Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:41:34Z   0 0 0900006484a5cf71
FDA-2016-N-3120-0530 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0043_m2_pk sum rep Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:58:14Z   0 0 0900006484a5ef4d
FDA-2016-N-3120-0537 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_m5_2015_3768 be_CSR Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:32:55Z   0 0 0900006484a5cfa5
FDA-2016-N-3120-0535 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2014-5-2_correspondence_26feb2014-email Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:06:57Z   0 0 0900006484a5f5f6
FDA-2016-N-3120-0522 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_2015_3768 ba Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:47:43Z   0 0 0900006484a5cf92
FDA-2016-N-3120-0513 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m5_ba be Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:39:35Z   0 0 0900006484a5cf67
FDA-2016-N-3120-0538 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0050_m1_Gen Corres_Sept 2015 Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:33:48Z   0 0 0900006484a5f5f4
FDA-2016-N-3120-0540 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2015-5-5_Meeting Request for ANDA 091695 Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:36:01Z   0 0 0900006484a5f699
FDA-2016-N-3120-0542 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 2015-6-26_ANDA 91695 Meeting Request Granted Letter Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:38:16Z   0 0 0900006484a5f69b
FDA-2016-N-3120-0523 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0042_2015_3769 be_CSR Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:49:55Z   0 0 0900006484a5cf94
FDA-2016-N-3120-0520 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0039_m1_Gen Corres_Req for Mtg Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T20:46:11Z   0 0 0900006484a5cf84
FDA-2016-N-3120-0550 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 ANDA 091695 Methylphenidate TSI 1349 Summary Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:48:21Z   0 0 0900006484a5f6c9
FDA-2016-N-3120-0555 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Letter Beers to Scheineson 5 14 19 Supporting & Related Material Background Material 2021-03-04T05:00:00Z 2021 3     2021-03-04T21:54:34Z   0 0 0900006484a5f6ff
FDA-2016-N-3120-0509 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0000_m5_5312 ba-be case rep forms Supporting & Related Material Background Material 2021-03-03T05:00:00Z 2021 3     2021-03-03T18:10:15Z   0 0 0900006484a5cf4c
FDA-2016-N-3120-0511 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m2_summary-biopharm Supporting & Related Material Background Material 2021-03-03T05:00:00Z 2021 3     2021-03-03T18:12:23Z   0 0 0900006484a5cf4e
FDA-2016-N-3120-0508 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0000_M5_5311bioavailiabilty_bioequivalence Supporting & Related Material Background Material 2021-03-03T05:00:00Z 2021 3     2021-03-03T18:09:07Z   0 0 0900006484a5cf4b
FDA-2016-N-3120-0507 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0000_M3_Des and Comp of Drug Product Supporting & Related Material Background Material 2021-03-03T05:00:00Z 2021 3     2021-03-03T18:05:19Z   0 0 0900006484a5cf47
FDA-2016-N-3120-0510 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_M1 Supporting & Related Material Background Material 2021-03-03T05:00:00Z 2021 3     2021-03-03T18:11:26Z   0 0 0900006484a5cf4d
FDA-2016-N-3120-0512 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 0007_m3_desc and comp Supporting & Related Material Background Material 2021-03-03T05:00:00Z 2021 3     2021-03-03T18:17:44Z   0 0 0900006484a5cf51
FDA-2016-N-3120-0505 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Letter Beers to Scheineson 3 7 19 Other Letter(s) 2019-04-12T04:00:00Z 2019 4 2019-04-12T04:00:00Z   2019-04-12T15:51:46Z   0 0 0900006483b8b981
FDA-2016-N-3120-0506 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 270_091695_Memo correction 11282018 Supporting & Related Material Background Material 2019-04-12T04:00:00Z 2019 4     2019-04-12T15:52:48Z   0 0 0900006483b8b7ec
FDA-2016-N-3120-0501 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Cover Letter for Supplemental Materials re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Other Letter(s) 2018-05-07T04:00:00Z 2018 5 2018-05-07T04:00:00Z   2018-05-07T12:22:50Z   0 0 0900006483235fba
FDA-2016-N-3120-0500 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Letter from Kremers Urban Pharmaceuticals Inc. (Alston & Bird) to FDA DDM Other Letter(s) 2018-05-03T04:00:00Z 2018 5 2018-05-03T04:00:00Z   2018-05-03T19:34:11Z   0 0 09000064832286a8
FDA-2016-N-3120-0495 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 "265_202608_Fasting Reanalysis" (Fed) Supporting & Related Material Background Material 2018-04-03T04:00:00Z 2018 4     2018-04-03T14:45:54Z   0 0 090000648302cdd9
FDA-2016-N-3120-0494 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Letter Beers to Scheineson 2 13 18 Other Letter(s) 2018-04-03T04:00:00Z 2018 4 2018-04-03T04:00:00Z   2018-04-03T14:44:23Z   0 0 090000648302cdd6
FDA-2016-N-3120-0498 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 268_091695_Fed Reanalysis Supporting & Related Material Background Material 2018-04-03T04:00:00Z 2018 4     2018-04-03T14:47:13Z   0 0 090000648302cddd
FDA-2016-N-3120-0497 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 267_091695_Fasting Reanalysis Supporting & Related Material Background Material 2018-04-03T04:00:00Z 2018 4     2018-04-03T14:46:52Z   0 0 090000648302cddc
FDA-2016-N-3120-0496 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 "266_202608_Fed Reanalysis" (Fasting) Supporting & Related Material Background Material 2018-04-03T04:00:00Z 2018 4     2018-04-03T14:46:31Z   0 0 090000648302cddb
FDA-2016-N-3120-0445 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 77 Massachusetts General Hospital, PK/PD Pediatric ADHD Classroom Study. NCT02536105 re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T19:16:36Z   0 0 0900006482d154cd
FDA-2016-N-3120-0469 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 101 Shram et al (2012). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T21:14:23Z   0 0 0900006482d154e5
FDA-2016-N-3120-0475 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 107 Stein et al (2003). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T21:38:24Z   0 0 0900006482d154eb
FDA-2016-N-3120-0489 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 121 Wigal, et al (1998). Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharm Bull, 34(1), 47-56. re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T22:08:06Z   0 0 0900006482d154f9
FDA-2016-N-3120-0484 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 116 Vitiello et al (2001). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T22:01:03Z   0 0 0900006482d154f4
FDA-2016-N-3120-0483 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 115 United States Pharmacopeia (USP), Convention (2017). Methylphenidate Hydrochloride Monograph re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T21:58:35Z   0 0 0900006482d154f3
FDA-2016-N-3120-0446 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 78 Micheal & Balamurali (2015). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T19:21:11Z   0 0 0900006482d154ce
FDA-2016-N-3120-0449 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 81 Modi et al (2000). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T19:32:06Z   0 0 0900006482d154d1
FDA-2016-N-3120-0457 FDA Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets FDA-2016-N-3120 Reference 89 Pera, G. (2011). What’s Up With Generic Concerta? re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird) Supporting & Related Material Reference (external attachments) 2017-12-27T05:00:00Z 2017 12     2017-12-27T19:48:35Z   0 0 0900006482d154d9

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