documents
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
This data as json, CSV (advanced)
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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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