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

339 rows where docket_id = "FDA-1987-N-0054" sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 4

posted_year 1

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1987-N-0054-0334 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Withdrawal Letter from Piper & Marbury to FDA DDM Other Withdrawal 2018-02-26T05:00:00Z 2018 2     2018-02-26T14:43:14Z   0 0 090000648046c812
FDA-1987-N-0054-0335 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications Notice Withdrawal 2018-02-26T05:00:00Z 2018 2 2018-02-26T05:00:00Z 1997-06-26T03:59:59Z 2018-02-26T14:44:26Z 97-16602 0 0 090000648046c813
FDA-1987-N-0054-0337 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications; Correction Notice Correction 2018-02-26T05:00:00Z 2018 2     2018-02-26T14:46:44Z 97-19012 0 0 090000648046c814
FDA-1987-N-0054-0332 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service Other Certificate of Service 2018-02-26T05:00:00Z 2018 2     2018-02-26T14:29:49Z   0 0 090000648046c810
FDA-1987-N-0054-0338 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Cover Letter from FDA DDM re Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications; Correction Other Letter(s) 2018-02-26T05:00:00Z 2018 2     2018-02-26T14:47:06Z   0 0 0900006482e64772
FDA-1987-N-0054-0336 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Cover Letter from FDA DDM re Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications Other Withdrawal 2018-02-26T05:00:00Z 2018 2     2018-02-26T14:45:13Z   0 0 0900006482e57cf2
FDA-1987-N-0054-0333 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Letter from Charles J. Raubicheck to FDA DDM Other Letter(s) 2018-02-26T05:00:00Z 2018 2     2018-02-26T14:41:41Z   0 0 090000648046c811
FDA-1987-N-0054-0339 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Withdrawal for Request of Hearing from Watson Laboratories Other Withdrawal 2018-02-26T05:00:00Z 2018 2     2018-02-26T14:48:07Z   0 0 090000648046c815
FDA-1987-N-0054-0325 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Request for Exception from Bolar Pharmaceutical Company, Inc. (King and Spalding) Other Certificate of Service 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:09:53Z   0 0 0900006482e54d4b
FDA-1987-N-0054-0319 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Request for Exception from Jones Medical Industries, Inc. (Kleinfeld, Kaplan & Becker) Other Exception/Waiver 2018-02-23T05:00:00Z 2018 2     2018-02-23T14:39:03Z   0 0 090000648046c809
FDA-1987-N-0054-0323 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company’s Exceptions to Initial Decision July 10, 1989 (Vol. 3 of 3) Supporting & Related Material Background Material 2018-02-23T05:00:00Z 2018 2     2018-02-23T14:58:23Z   0 0 0900006482e4c1e9
FDA-1987-N-0054-0329 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Center's Response to Warner -Lambert's Motion to Reopen the Administration Record and to Remand from FDA CDER Other Reply 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:31:32Z   0 0 090000648046c80e
FDA-1987-N-0054-0328 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company's Motion to Reopen the Administrative Record and to Remand Other Motion 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:30:58Z   0 0 090000648046c80d
FDA-1987-N-0054-0331 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Order Denying Warner -Lambert's Motion to Reopen The Administrative Record from FDA Other Order 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:33:22Z   0 0 090000648046c80f
FDA-1987-N-0054-0322 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company’s Exceptions to Initial Decision July 10, 1989 (Vol. 2 of 3) Supporting & Related Material Background Material 2018-02-23T05:00:00Z 2018 2     2018-02-23T14:57:56Z   0 0 0900006482e29143
FDA-1987-N-0054-0324 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Request for Exception from Bolar Pharmaceutical Company, Inc. (King and Spalding) Other Exception/Waiver 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:00:19Z   0 0 090000648046c80b
FDA-1987-N-0054-0318 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Disclosure of Data and Information from Jones Medical Industries, Inc. Other Certificate of Service 2018-02-23T05:00:00Z 2018 2     2018-02-23T14:34:36Z   0 0 090000648046c808
FDA-1987-N-0054-0327 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Response to Warner- Lambert's Exceptions to the Initial Decision from FDA CDER Other Certificate of Service 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:12:08Z   0 0 0900006482e54d4d
FDA-1987-N-0054-0330 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Center's Response to Warner -Lambert's Motion to Reopen the Administration Record and to Remand from FDA CDER Other Certificate of Service 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:31:52Z   0 0 0900006482e54f3a
FDA-1987-N-0054-0326 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Response to Warner- Lambert's Exceptions to the Initial Decision from FDA CDER Other Reply 2018-02-23T05:00:00Z 2018 2     2018-02-23T15:11:37Z   0 0 090000648046c80c
FDA-1987-N-0054-0320 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Request for Exception from Jones Medical Industries, Inc. (Kleinfeld, Kaplan & Becker) Other Certificate of Service 2018-02-23T05:00:00Z 2018 2     2018-02-23T14:56:56Z   0 0 0900006482e54738
FDA-1987-N-0054-0321 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company’s Exceptions to Initial Decision July 10, 1989 (Vol. 1 of 3) Other Exception/Waiver 2018-02-23T05:00:00Z 2018 2     2020-01-31T06:55:32Z   0 0 090000648046c80a
FDA-1987-N-0054-0317 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Letter from Warner-Lambert Company to Honorable Daniel J. Davidson Other Letter(s) 2018-02-21T05:00:00Z 2018 2     2018-02-21T16:48:08Z   0 0 090000648046c806
FDA-1987-N-0054-0313 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Post-Hearing Brief of Bolar Pharmaceutical Company, Inc. Other Brief 2018-02-21T05:00:00Z 2018 2     2018-02-21T16:08:49Z   0 0 090000648046c802
FDA-1987-N-0054-0303 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Exhibits G-201, G-202, G-244 thru G-247 re: Parties' Master Evidence List from FDA Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T13:37:54Z   0 0 0900006482e31295
FDA-1987-N-0054-0302 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Parties' Master Evidence List from FDA CDER Other Certificate of Service 2018-02-21T05:00:00Z 2018 2     2018-02-21T13:35:59Z   0 0 0900006482e30586
FDA-1987-N-0054-0301 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Index re: Parties' Master Evidence List from FDA CDER Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T13:35:15Z   0 0 0900006482e54d86
FDA-1987-N-0054-0315 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Brief of Jones Medical Industries, Inc. and Inwood Laboratories, Inc. Other Brief 2018-02-21T05:00:00Z 2018 2     2018-02-21T16:12:08Z   0 0 090000648046c803
FDA-1987-N-0054-0314 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Post-Hearing Brief of Bolar Pharmaceutical Company, Inc. Other Certificate of Service 2018-02-21T05:00:00Z 2018 2     2018-02-21T16:09:15Z   0 0 0900006482e305f9
FDA-1987-N-0054-0308 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Exhibits B-001 through B-003B re: Parties' Master Evidence List from FDA CDER Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:46:41Z   0 0 0900006482e4bebd
FDA-1987-N-0054-0316 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Brief of Jones Medical Industries, Inc. and Inwood Laboratories, Inc. Other Certificate of Service 2018-02-21T05:00:00Z 2018 2     2020-01-31T06:56:04Z   0 0 0900006482e2fcbd
FDA-1987-N-0054-0307 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Index of Exhibits B-001 thru B-003B re: Parties' Master Evidence List from FDA CDER Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:46:27Z   0 0 0900006482e5599a
FDA-1987-N-0054-0304 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Exhibits G-256 thru G-281 re: Parties' Master Evidence List from FDA Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:37:44Z   0 0 0900006482e2fcbf
FDA-1987-N-0054-0305 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Exhibits G-249 thru G-255A. re: Parties' Master Evidence List from FDA Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:38:52Z   0 0 0900006482e30a3f
FDA-1987-N-0054-0300 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Parties' Master Evidence List from FDA CDER Other List (LST) 2018-02-21T05:00:00Z 2018 2     2018-02-21T13:34:29Z   0 0 090000648046c7ff
FDA-1987-N-0054-0310 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Table of Contents for Exhibits W-1 thru W-101 re: Parties' Master Evidence List from FDA CDER Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:47:47Z   0 0 0900006482e54e8b
FDA-1987-N-0054-0312 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company's Post-Hearing Brief Other Brief 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:49:32Z   0 0 090000648046c801
FDA-1987-N-0054-0311 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Brief for the Center for Drug Evaluation and Research Other Brief 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:48:54Z   0 0 090000648046c800
FDA-1987-N-0054-0309 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Index of Exhibits W-1 thru W-123 re: Parties' Master Evidence List from FDA CDER Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:47:35Z   0 0 0900006482e54d81
FDA-1987-N-0054-0306 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Exhibits G-282 thru G-298. re: Parties' Master Evidence List from FDA Supporting & Related Material Background Material 2018-02-21T05:00:00Z 2018 2     2018-02-21T15:46:04Z   0 0 0900006482e300da
FDA-1987-N-0054-0299 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service from Lyle D. Jaffe Other Certificate of Service 2018-02-20T05:00:00Z 2018 2     2018-02-20T13:55:11Z   0 0 090000648046c7fe
FDA-1987-N-0054-0296 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company's Motion for Enlargement of Time in Which to File Briefs Other Motion 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:42:48Z   0 0 090000648046c7fc
FDA-1987-N-0054-0277 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Center's Response to Warner-Lambert's Motion to Readmit Strickened Evidence Other Response(s) 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:33:36Z   0 0 090000648046c7f1
FDA-1987-N-0054-0298 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Motion to Strike Participation of Armour Pharmaceutical CO. from FDA CDER Other Motion 2018-02-16T05:00:00Z 2018 2 2018-02-16T05:00:00Z   2018-02-16T16:45:20Z   0 0 090000648046c7a7
FDA-1987-N-0054-0295 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service from Lyle D. Jaffe Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:42:15Z   0 0 090000648046c7fb
FDA-1987-N-0054-0292 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lamber Company's Opposition to Center's Application to Renew Motion to Strike Other Reply 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:40:53Z   0 0 090000648046c7f9
FDA-1987-N-0054-0284 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Letter from Warner-Lambert Company (Davis Hoxie Faithfull & Hapgood) Other Letter(s) 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:37:20Z   0 0 090000648046c7f5
FDA-1987-N-0054-0281 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Warner-Lambert Company's Motion to Add a Witness and to Readmit Evidence into the Evidentiary Record Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:35:42Z   0 0 0900006482e2f8cc
FDA-1987-N-0054-0287 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Application to Renew Motion to Strike from FDA CDER Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:38:37Z   0 0 0900006482e2ef03
FDA-1987-N-0054-0285 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Letter from Warner-Lambert Company (Davis Hoxie Faithfull & Hapgood) Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:37:42Z   0 0 0900006482e2eea2
FDA-1987-N-0054-0268 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Response to Motion for Leave to Ask Questions on Oral Direct Examination from Warner -Lambert Company (Davis, Hoxie, et al) Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:04:38Z   0 0 0900006482e52f0c
FDA-1987-N-0054-0266 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:03:37Z   0 0 090000648046c7eb
FDA-1987-N-0054-0282 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Response to Warner-lambert Company's Motion to Add a Witness and to Readmit Evidence into the Evidentiary Record Other Reply 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:36:17Z   0 0 090000648046c7f4
FDA-1987-N-0054-0290 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Center's Response to Warner-Lambert Company's Motion to Readmit Evidence Other Reply 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:39:59Z   0 0 090000648046c7f8
FDA-1987-N-0054-0283 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Response to Warner-lambert Company's Motion to Add a Witness and to Readmit Evidence into the Evidentiary Record Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:36:35Z   0 0 0900006482e2e3d9
FDA-1987-N-0054-0286 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Application to Renew Motion to Strike from FDA CDER Other Motion 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:38:18Z   0 0 090000648046c7f6
FDA-1987-N-0054-0279 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Questions for Warner-Lambert Company's Oral Direct Testimony (Davis, Hoxie, et al) Other Letter(s) 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:34:47Z   0 0 090000648046c7f2
FDA-1987-N-0054-0272 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Response to Application for Limited Additional Oral Direct Testimony from FDA CDER Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:56:37Z   0 0 0900006482e53003
FDA-1987-N-0054-0288 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company's Motion to Readmit Evidence Other Motion 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:39:08Z   0 0 090000648046c7f7
FDA-1987-N-0054-0294 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Order in the Matter of Pentaerythritol Tetranitrate: Proposal to Withdraw Approval of Certain New Drug Applications Other Order 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:41:47Z   0 0 090000648046c7fa
FDA-1987-N-0054-0291 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Center's Response to Warner-Lambert Company's Motion to Readmit Evidence Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:40:21Z   0 0 0900006482e301e5
FDA-1987-N-0054-0289 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Warner-Lambert Company's Motion to Readmit Evidence Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:39:26Z   0 0 0900006482e2ef57
FDA-1987-N-0054-0267 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Response to Motion for Leave to Ask Questions on Oral Direct Examination from Warner- Lambert Company (Davis, Hoxie, et al) Other Response(s) 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:04:21Z   0 0 090000648046c7ec
FDA-1987-N-0054-0276 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Errata Notice Correcting Schedule for Cross -Examination of Dr. Leung from FDA CDER Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:33:00Z   0 0 0900006482e530c3
FDA-1987-N-0054-0269 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Motion to Readmit Evidence Stricken from Evidentiary Record from Warner -Lambert Company (Davis, Hoxie, et al) Other Motion 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:55:01Z   0 0 090000648046c7ed
FDA-1987-N-0054-0278 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Response to Motion to Readmit Strickened Evidence from FDA CDER Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:33:56Z   0 0 0900006482e53970
FDA-1987-N-0054-0273 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Amended Schedule for Cross- Examination from FDA CDER Other Letter(s) 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:57:47Z   0 0 090000648046c7ef
FDA-1987-N-0054-0270 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Motion to Readmit Evidence Stricken from Evidentiary Record from Warner -Lambert Company (Davis, Hoxie, et al) Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:55:18Z   0 0 0900006482e52f10
FDA-1987-N-0054-0274 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Amended Schedule for Cross- Examination from FDA CDER Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:59:11Z   0 0 0900006482e53526
FDA-1987-N-0054-0275 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Errata Notice Correcting Schedule for Cross- Examination of Dr. Leung from FDA CDER Other Correction(s) 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:32:43Z   0 0 090000648046c7f0
FDA-1987-N-0054-0271 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Response to Application for Limited Additional Oral Direct Testimony from FDA CDER Other Response(s) 2018-02-16T05:00:00Z 2018 2     2018-02-16T14:56:20Z   0 0 090000648046c7ee
FDA-1987-N-0054-0280 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Warner-Lambert Company's Motion to Add a Witness and to Readmit Evidence into the Evidentiary Record Other Motion 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:35:25Z   0 0 090000648046c7f3
FDA-1987-N-0054-0297 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Warner-Lambert Company's Motion for Enlargement of Time in Which to File Briefs Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:43:04Z   0 0 0900006482e30063
FDA-1987-N-0054-0293 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Warner-Lamber Company's Opposition to Center's Application to Renew Motion to Strike Other Certificate of Service 2018-02-16T05:00:00Z 2018 2     2018-02-16T16:41:15Z   0 0 0900006482e2fea3
FDA-1987-N-0054-0238 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Notice of Witnesses to Be Cross -Examined from Bolar Pharmaceutical Company, Inc. Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:42:55Z   0 0 0900006482e4d135
FDA-1987-N-0054-0240 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Notice of Withdrawal of Direct Testimony from FDA CDER Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:44:19Z   0 0 0900006482e4d1d9
FDA-1987-N-0054-0233 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Notice of Cross-Examination of Hearing Witnesses from Warner-Lambert Company (Davis, Hoxie, et al.) Other List (LST) 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:35:59Z   0 0 090000648046c7d7
FDA-1987-N-0054-0248 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Uncontested Motion for Enlargement of Time from Warner- Lambert Company (Stovall and Spradlin) Other Motion 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:02:18Z   0 0 090000648046c7e0
FDA-1987-N-0054-0257 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Motion for Leave to Ask Questions on Oral Direct Examination from FDA Other Motion 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:14:41Z   0 0 090000648046c7e6
FDA-1987-N-0054-0262 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Amended Schedule of Cross -Examination of Hearing Witnesses from Warner -Lambert Company (Davis, Hoxie, et al) Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:50:38Z   0 0 0900006482e502f8
FDA-1987-N-0054-0247 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Motion for Certification of Interlocutory Appeal from Warner-Lambert Company Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:49:54Z   0 0 0900006482e4d36b
FDA-1987-N-0054-0234 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Notice of Cross- Examination of Hearing Witnesses from Warner- Lambert Company (Davis, Hoxie, et al.) Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:36:15Z   0 0 0900006482e4c8b1
FDA-1987-N-0054-0246 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Motion for Certification of Interlocutory Appeal from Warner-Lambert Company Other Motion 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:49:31Z   0 0 090000648046c7df
FDA-1987-N-0054-0263 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Correction of Typographical Error in Stipulated Amendment from Warner -Lambert Company (Stovall & Spradlin) Other Correction(s) 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:51:26Z   0 0 090000648046c7e9
FDA-1987-N-0054-0250 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Correction of Typographical & Collation Errors from Warner-Lambert Company (Stovall & Spradlin) Other Correction(s) 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:03:49Z   0 0 090000648046c7e1
FDA-1987-N-0054-0232 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Tab #48 Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T13:42:14Z   0 0 090000648046c7d6
FDA-1987-N-0054-0258 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Motion for Leave to Ask Questions on Oral Direct Examination from FDA Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:15:28Z   0 0 0900006482e4ff6d
FDA-1987-N-0054-0264 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Correction of Typographical Error in Stipulated Amendment from Warner- Lambert Company (Stovall & Spradlin) Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:51:44Z   0 0 0900006482e5063c
FDA-1987-N-0054-0236 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Notice of Witnesses to Be Cross -Examined from Inwood Labs Inc et al (Kleinfeld, Kaplan and Becker) Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:40:33Z   0 0 0900006482e4cd71
FDA-1987-N-0054-0245 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:48:36Z   0 0 090000648046c7de
FDA-1987-N-0054-0252 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:06:23Z   0 0 090000648046c7e3
FDA-1987-N-0054-0235 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Notice of Witnesses to be Cross- Examined from Inwood Labs Inc et al (Kleinfeld, Kaplan and Becker) Other List (LST) 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:39:51Z   0 0 090000648046c7d8
FDA-1987-N-0054-0237 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Notice of Witnesses to Be Cross-Examined from Bolar Pharmaceutical Company, Inc. Other List (LST) 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:42:34Z   0 0 090000648046c7d9
FDA-1987-N-0054-0241 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Opposition to Notice of Withdrawal of Direct Testimony & Motion for Enforcement of Prior Order from Warner -Lambert Company (Davis, Hoxie, et al) Other Motion 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:45:40Z   0 0 090000648046c7db
FDA-1987-N-0054-0259 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Application for Limited Additional Oral Direct Testimony from Warner -Lambert Company (Davis, Hoxie, et al) Other Motion 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:16:26Z   0 0 090000648046c7e7
FDA-1987-N-0054-0249 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Uncontested Motion for Enlargement of Time from Warner- Lambert Company (Stovall and Spradlin) Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:02:43Z   0 0 0900006482e4e889
FDA-1987-N-0054-0261 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Amended Schedule of Cross- Examination of Hearing Witnesses from Warner -Lambert Company (Davis, Hoxie, et al) Other Letter(s) 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:50:23Z   0 0 090000648046c7e8
FDA-1987-N-0054-0242 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Opposition to Notice of Withdrawal of Direct Testimony & Motion for Enforcement of Prior Order from Warner-Lambert Company (Davis, Hoxie, et al) Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T14:45:58Z   0 0 0900006482e4d916
FDA-1987-N-0054-0256 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Response to Motion for Certification of Interlocutory Appeal from FDA Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:11:05Z   0 0 0900006482e4f6de
FDA-1987-N-0054-0260 FDA Pentaerythritol Tetranitrate (PETN) - Open FDA-1987-N-0054 Certificate of Service re: Application for Limited Additional Oral Direct Testimony from Warner- Lambert Company (Davis, Hoxie, et al) Other Certificate of Service 2018-02-15T05:00:00Z 2018 2     2018-02-15T15:16:53Z   0 0 0900006482e4ff73

Next page

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);