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withdrawn,object_id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-2020-E-2363-0001,FDA,FDA-2020-E-2363,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:46:23Z,,0,0,09000064849d6369
FDA-2020-E-2364-0002,FDA,FDA-2020-E-2364,"Patent Term Extension Application for NURTEC ODT® Patent No 8,314,117",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:56:21Z,,0,0,09000064849d636f
FDA-2020-E-2361-0002,FDA,FDA-2020-E-2361,"Patent Term Extension Application for ENSPRYNG® Patent No 8,562,991",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:33:58Z,,0,0,09000064849d615c
FDA-2020-E-2365-0002,FDA,FDA-2020-E-2365,"Patent Term Extension Application for NURTEC ODT® Patent No 8,759,372",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T15:04:43Z,,0,0,09000064849d63e4
FDA-2020-E-2364-0001,FDA,FDA-2020-E-2364,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:55:22Z,,0,0,09000064849d636e
FDA-2020-E-2363-0002,FDA,FDA-2020-E-2363,"Patent Term Extension Application for ENSPRYNG® Patent No 10,662,245",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:47:19Z,,0,0,09000064849d636a
FDA-2020-P-1769-0011,FDA,FDA-2020-P-1769,Response letter to Siri & Glimstad LLP from FDA CBER,Other,Response(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T18:19:46Z,,0,0,09000064849d6b35
FDA-2016-N-0124-0410,FDA,FDA-2016-N-0124,"Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small
Entity Compliance Guide; Availability",Notice,Notice of Availability,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:14:51Z,2020-28929,0,0,09000064849d654d
FDA-2020-E-2365-0001,FDA,FDA-2020-E-2365,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T15:03:44Z,,0,0,09000064849d63e3
FDA-2020-E-2362-0001,FDA,FDA-2020-E-2362,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:39:30Z,,0,0,09000064849d615f
FDA-2020-E-2362-0002,FDA,FDA-2020-E-2362,"Patent Term Extension Application for ENSPRYNG® Patent No 10,022,319",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:40:22Z,,0,0,09000064849d6366
FDA-2020-E-2361-0001,FDA,FDA-2020-E-2361,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:33:04Z,,0,0,09000064849d615b
FDA-2020-V-2292-0003,FDA,FDA-2020-V-2292,Variance Approval Letter from FDA CDRH to Irani Silva,Other,Approval for Variance (VRA),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T16:11:07Z,,0,0,09000064849d63ea
FDA-2016-N-0124-0411,FDA,FDA-2016-N-0124,"Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small
Entity Compliance Guide; Availability",Other,Guidance,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2024-11-12T23:26:51Z,,1,0,09000064849d6159
FDA-2015-P-0703-0003,FDA,FDA-2015-P-0703,Citizen Petition Response to Sarah Salem-Robinson,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T16:53:12Z,,0,0,09000064849d2636
FDA-2020-V-2282-0003,FDA,FDA-2020-V-2282,Variance Approval Letter from FDA CDRH to  MicaTronics LLC,Other,Approval for Variance (VRA),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T16:33:49Z,,0,0,09000064849d20ba
FDA-2018-P-2073-0005,FDA,FDA-2018-P-2073,Citizen Petition Response to LMS Direct Research Foundation,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T17:00:45Z,,0,0,09000064849d22af
FDA-2020-P-2360-0001,FDA,FDA-2020-P-2360,Citizen Petition from Pet Schooled The Educated Community,Other,Citizen Petition,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2024-11-12T23:26:46Z,,1,0,09000064849d0890
FDA-2020-P-2357-0001,FDA,FDA-2020-P-2357,"Citizen Petition from Keller and Heckman LLP on behalf of Nexira, Alland & Robert and Importers Service Corporation",Other,Citizen Petition,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2021-12-17T13:56:39Z,,0,0,09000064849ce2e5
FDA-2020-P-2357-0002,FDA,FDA-2020-P-2357,"Acknowledgment Letter from FDA DMS to Keller and Heckman LLP n behalf of Nexira, Alland & Robert, and Importers Service Corporation",Other,Acknowledgement Letter/Receipt,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T13:41:28Z,,0,0,09000064849ce2e6
FDA-2020-P-2360-0002,FDA,FDA-2020-P-2360,Acknowledgment Letter from FDA DMS to Pet Schooled,Other,Acknowledgement Letter/Receipt,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2024-11-12T23:26:29Z,,1,0,09000064849d20b5
FDA-2014-D-1804-0073,FDA,FDA-2014-D-1804,"Product Labeling for Laparoscopic Power Morcellators; Guidance for
Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T13:31:56Z,2020-28816,0,0,09000064849d16c7
FDA-2016-P-1398-0004,FDA,FDA-2016-P-1398,Citizen Petition Response to Dr. Hooman Noorchashm,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T17:01:11Z,,0,0,09000064849d263b
FDA-2020-P-2357-0003,FDA,FDA-2020-P-2357,"Appendix I Uebelhack re Citizen Petition from Keller and Heckman LLP on behalf of Nexira, Alland & Robert and Importers Service Corporation",Supporting & Related Material,Background Material,2020-12-30T05:00:00Z,2020,12,,,2020-12-30T13:41:37Z,,0,0,09000064849ce2e9
FDA-2018-N-3233-0002,FDA,FDA-2018-N-3233,"Request for Nominations for Voting Members on a Public Advisory
Committee; Technical Electronic Product Radiation Safety Standards
Committee",Notice,Request for Nominations,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T13:28:30Z,2020-28833,0,0,09000064849d18c9
FDA-2018-P-3843-0115,FDA,FDA-2018-P-3843,Citizen Petition Response to Hoomad Noorchashm,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T17:06:07Z,,0,0,09000064849d22b1
FDA-2014-D-1804-0074,FDA,FDA-2014-D-1804,"Product Labeling for Laparoscopic Power Morcellators; Guidance for
Industry and Food and Drug Administration Staff",Other,Guidance,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2024-11-12T23:26:46Z,,1,0,09000064849d088d
FDA-2020-V-2356-0001,FDA,FDA-2020-V-2356,Variance Application from  La Farm Animal Save,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T16:42:59Z,,0,0,09000064849cd180
FDA-2020-N-2246-0001,FDA,FDA-2020-N-2246,Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,Notice,Announcement,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:03:53Z,2020-28714,0,0,09000064849cfd28
FDA-2020-V-2356-0002,FDA,FDA-2020-V-2356,Acknowledgment Letter from FDA DMS to La Farm Animal Save,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T16:46:33Z,,0,0,09000064849cd7a6
FDA-2020-V-2350-0001,FDA,FDA-2020-V-2350,Variance Application from Jurijus Voronovas,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T14:41:00Z,,0,0,09000064849cb3a9
FDA-2020-V-2346-0002,FDA,FDA-2020-V-2346,Acknowledgment Letter from FDA DMS to Jayden Romay Ruiz,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:15:26Z,,0,0,09000064849cbcad
FDA-2020-V-2347-0001,FDA,FDA-2020-V-2347,Variance Application from Silverhawk Aviation,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:11:33Z,,0,0,09000064849cbd6b
FDA-2020-V-2350-0002,FDA,FDA-2020-V-2350,Acknowledgment Letter from FDA DMS to Jurijus Voronovas,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T14:46:47Z,,0,0,09000064849cbccc
FDA-2010-N-0493-0013,FDA,FDA-2010-N-0493,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:10:19Z,2020-28608,0,0,09000064849cfdc6
FDA-2020-V-2345-0002,FDA,FDA-2020-V-2345,Acknowledgment Letter from FDA DMS to Shane Cassidy,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T15:06:38Z,,0,0,09000064849cb3a5
FDA-2017-N-2021-0007,FDA,FDA-2017-N-2021,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:10:55Z,2020-28608,0,0,09000064849cfe9f
FDA-2020-V-2347-0002,FDA,FDA-2020-V-2347,Acknowledgement Letter from FDA DMS to Silverhawk Aviation,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:11:47Z,,0,0,09000064849cbd71
FDA-2017-N-1095-0009,FDA,FDA-2017-N-1095,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:12:08Z,2020-28608,0,0,09000064849cfe9d
FDA-2020-V-2346-0001,FDA,FDA-2020-V-2346,Variance Application from Jayden Romay Ruiz,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:15:10Z,,0,0,09000064849cb9a4
FDA-2020-P-1633-0005,FDA,FDA-2020-P-1633,"Interim Response Letter from FDA CBER to Foley Hoag, LLP (on behalf of the Microbiome Therapeutics Innovation Group)",Other,Letter(s),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T20:33:10Z,,0,0,09000064849d0105
FDA-2020-D-1825-0015,FDA,FDA-2020-D-1825,Investigational COVID-19 Convalescent Plasma Guidance for Industry,Other,Guidance,2020-12-29T05:00:00Z,2020,12,2021-01-04T05:00:00Z,,2024-11-06T23:44:24Z,,1,0,09000064849dc6c4
FDA-2020-V-2344-0002,FDA,FDA-2020-V-2344,Acknowledgment Letter from FDA DMS to Joshua Coonradt,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:17:52Z,,0,0,09000064849cb386
FDA-2012-N-0197-0010,FDA,FDA-2012-N-0197,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:12:34Z,2020-28608,0,0,09000064849cfe9c
FDA-2011-N-0424-0011,FDA,FDA-2011-N-0424,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:11:23Z,2020-28608,0,0,09000064849cfe9e
FDA-2020-V-2345-0001,FDA,FDA-2020-V-2345,Variance Application from  Shane Cassidy,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T15:02:00Z,,0,0,09000064849cb27f
FDA-2020-V-2344-0001,FDA,FDA-2020-V-2344,Variance Application from Joshua Coonradt,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:17:30Z,,0,0,09000064849cb2cb
FDA-2020-N-2252-0001,FDA,FDA-2020-N-2252,Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act; Public Meeting; Request for Comments,Notice,Request for Comments,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,2021-03-30T03:59:59Z,2021-03-30T01:00:27Z,2020-28602,0,0,09000064849cc7ab
FDA-2020-V-2321-0002,FDA,FDA-2020-V-2321,Acknowledgment Letter from FDA DMS to Zachary Taylor,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T14:40:16Z,,0,0,09000064849bb5e2
FDA-2020-V-2348-0002,FDA,FDA-2020-V-2348,Acknowledgment Letter from FDA DMS to Below the Waves LLC,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:41:48Z,,0,0,09000064849cb2cd
FDA-2020-V-2348-0001,FDA,FDA-2020-V-2348,Variance Application from Below the Waves LLC,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:40:51Z,,0,0,09000064849cb2c9
FDA-2020-D-0530-0668,FDA,FDA-2020-D-0530,"Voluntary Disclosure of Sesame as an
Allergen: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Comment Period",Notice,Notice of Availability,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,2021-02-26T04:59:59Z,2021-02-27T02:00:26Z,2020-28559,0,0,09000064849cc892
FDA-2017-D-4303-0003,FDA,FDA-2017-D-4303,Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T16:56:08Z,2020-28560,0,0,09000064849cc7af
FDA-2020-V-2352-0001,FDA,FDA-2020-V-2352,Variance Application from  Gregory Class,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T20:18:43Z,,0,0,09000064849cbe4d
FDA-2020-N-1440-0001,FDA,FDA-2020-N-1440,Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,2021-02-09T04:59:59Z,2021-02-10T02:00:46Z,2020-28558,0,0,09000064849cc88e
FDA-2020-V-2349-0001,FDA,FDA-2020-V-2349,Variance Application from John Nelson,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:42:29Z,,0,0,09000064849cb380
FDA-2020-V-2351-0002,FDA,FDA-2020-V-2351,Acknowledgment Letter from FDA DMS to One Source Media Solutions,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:49:56Z,,0,0,09000064849cbd6f
FDA-2020-V-2321-0001,FDA,FDA-2020-V-2321,Variance Application from Zachary Taylor,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T14:39:34Z,,0,0,09000064849bb5df
FDA-2020-N-0008-0022,FDA,FDA-2020-N-0008,"Advisory Committee; Cellular, Tissue and Gene Therapies Advisory
Committee; Renewal",Notice,Renewals,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T16:53:17Z,2020-28561,0,0,09000064849cc890
FDA-2020-V-2352-0002,FDA,FDA-2020-V-2352,Acknowledgment Letter from FDA DMS to Gregory Class,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T20:20:57Z,,0,0,09000064849ccac9
FDA-2020-V-2351-0001,FDA,FDA-2020-V-2351,Variance Application from One Source Media Solutions,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:49:04Z,,0,0,09000064849cbd6d
FDA-2020-V-2349-0002,FDA,FDA-2020-V-2349,Acknowledgment Letter from FDA DMS to John Nelson,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:48:27Z,,0,0,09000064849cb383
FDA-2020-E-2337-0001,FDA,FDA-2020-E-2337,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:31:44Z,,0,0,09000064849c11a1
FDA-2020-E-2337-0002,FDA,FDA-2020-E-2337,"Patent Term Extension Application for ROZLYTREK® Patent No 9,085,565",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:32:55Z,,0,0,09000064849c11a2
FDA-2020-V-2320-0002,FDA,FDA-2020-V-2320,Acknowledgment Letter from FDA DMS to Neil Hotkiewicz,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T12:49:14Z,,0,0,09000064849bb5dc
FDA-2020-P-2008-0006,FDA,FDA-2020-P-2008,Interim Response Letter from FDA CDRH to Philips Respironics,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T14:06:37Z,,0,0,09000064849c1209
FDA-2020-V-2342-0002,FDA,FDA-2020-V-2342,Acknowledgment Letter from FDA DMS to Chris Cook,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T20:25:34Z,,0,0,09000064849c2508
FDA-2020-V-2341-0001,FDA,FDA-2020-V-2341,Variance Application from FiveAM Theater,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:21:30Z,,0,0,09000064849c2113
FDA-2020-V-2188-0003,FDA,FDA-2020-V-2188,Variance Approval Letter from FDA CDRH to SONY Corporation,Other,Approval for Variance (VRA),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T14:57:35Z,,0,0,09000064849c120d
FDA-2020-E-2334-0002,FDA,FDA-2020-E-2334,"Patent Term Extension Application for ROZLYTREK® Patent No 8,673,893",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:10:17Z,,0,0,09000064849c0c38
FDA-2020-E-2338-0001,FDA,FDA-2020-E-2338,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:38:21Z,,0,0,09000064849c11a5
FDA-2020-N-2272-0001,FDA,FDA-2020-N-2272,"Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug Applications",Notice,Withdrawal,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T15:00:57Z,2020-28346,0,0,09000064849c0835
FDA-2020-V-2342-0001,FDA,FDA-2020-V-2342,Variance Application from Chris Cook,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T20:24:51Z,,0,0,09000064849c211b
FDA-2020-E-2334-0001,FDA,FDA-2020-E-2334,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:09:00Z,,0,0,09000064849c0c37
FDA-2020-V-2320-0001,FDA,FDA-2020-V-2320,Variance Application from Neil Hotkiewicz,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T12:46:17Z,,0,0,09000064849b9020
FDA-2020-E-2333-0001,FDA,FDA-2020-E-2333,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:01:31Z,,0,0,09000064849c0a4b
FDA-2010-N-0155-0253,FDA,FDA-2010-N-0155,Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive,Notice,60 Day Proposed Information Collection,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,2021-02-23T04:59:59Z,2020-12-23T15:07:58Z,2020-28353,0,0,09000064849c0f93
FDA-2020-N-2267-0001,FDA,FDA-2020-N-2267,"Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets",Notice,Withdrawal,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T15:11:29Z,2020-28283,0,0,09000064849c0fe7
FDA-2020-V-2343-0002,FDA,FDA-2020-V-2343,Acknowledgment Letter from FDA DMS to Ben Black,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:24:59Z,,0,0,09000064849c142f
FDA-2020-D-1136-0044,FDA,FDA-2020-D-1136,Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry,Other,Guidance,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,2023-05-12T03:59:59Z,2023-05-08T19:02:22Z,,0,0,09000064849bcedf
FDA-2020-E-2335-0001,FDA,FDA-2020-E-2335,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:15:28Z,,0,0,09000064849c1160
FDA-2020-E-2336-0001,FDA,FDA-2020-E-2336,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:22:21Z,,0,0,09000064849c1164
FDA-2020-P-2010-0007,FDA,FDA-2020-P-2010,Interim Response Letter from FDA CDRH to Philips Respironics,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T14:01:45Z,,0,0,09000064849c1206
FDA-2020-P-2322-0002,FDA,FDA-2020-P-2322,Acknowledgment Letter from FDA DMS to Covington & Burling LLP on behalf of Pharmaceutical Research and Manufacturers of America,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:43:35Z,,0,0,09000064849bae17
FDA-2020-E-2336-0002,FDA,FDA-2020-E-2336,"Patent Term Extension Application for ROZLYTREK® Patent No 9,029,356",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:25:27Z,,0,0,09000064849c1165
FDA-2020-E-2338-0002,FDA,FDA-2020-E-2338,"Patent Term Extension Application for ROZLYTREK® Patent No 9,085,565",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:39:55Z,,0,0,09000064849c11a6
FDA-2020-V-2205-0004,FDA,FDA-2020-V-2205,"Variance Approval Letter from FDA CDRH to MultiMedia Consulting Services, Inc",Other,Approval for Variance (VRA),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T21:09:03Z,,0,0,09000064849c5891
FDA-2020-E-2333-0002,FDA,FDA-2020-E-2333,"Patent Term Extension Application for ROZLYTREK® Patent No 8,299,057",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:02:47Z,,0,0,09000064849c0a4c
FDA-2020-E-2335-0002,FDA,FDA-2020-E-2335,"Patent Term Extension Application for ROZLYTREK® Patent No 9,029,356",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:16:33Z,,0,0,09000064849c1161
FDA-2017-D-4303-0002,FDA,FDA-2017-D-4303,Guidance for Industry REMS.eSub,Other,Guidance,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2024-11-12T23:27:37Z,,1,0,09000064849c3775
FDA-2014-N-0386-0005,FDA,FDA-2014-N-0386,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs,Notice,30 Day Proposed Information Collection,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,2021-01-23T04:59:59Z,2021-01-23T02:02:30Z,2020-28349,0,0,09000064849c0f39
FDA-2020-V-2343-0001,FDA,FDA-2020-V-2343,Variance Application from Ben Black,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:23:13Z,,0,0,09000064849c142c
FDA-2020-V-2341-0002,FDA,FDA-2020-V-2341,Acknowledgment Letter from FDA DMS to FiveAM Theater,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:22:09Z,,0,0,09000064849c2114
FDA-2020-P-2322-0001,FDA,FDA-2020-P-2322,Citizen Petition from Covington & Burling LLP on behalf of Pharmaceutical Research and Manufacturers of America,Other,Citizen Petition,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2024-11-12T23:26:39Z,,1,0,09000064849bae16
FDA-2020-P-2317-0001,FDA,FDA-2020-P-2317,Citizen Petition from Baxter Healthcare Corporation,Other,Citizen Petition,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2024-11-12T23:27:19Z,,1,0,09000064849b07a7
FDA-2020-V-2198-0003,FDA,FDA-2020-V-2198,Variance Approval Letter from CDRH to Old Dominion University,Other,Approval for Variance (VRA),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T14:48:03Z,,0,0,09000064849b7b8d
FDA-2020-E-2325-0002,FDA,FDA-2020-E-2325,"Patent Term Extension Application for ROZLYTREK® Patent No 8,299,057",Other,Application,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T21:17:46Z,,0,0,09000064849bd25b
FDA-2020-P-2318-0001,FDA,FDA-2020-P-2318,"Suitability Citizen Petition from Lachman Consulting Services, Inc.",Other,Petition(s),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2024-11-12T23:26:39Z,,1,0,09000064849b0718
FDA-2020-P-2318-0002,FDA,FDA-2020-P-2318,"Acknowledgement Letter from FDA DMS to Lachman Consulting Services, Inc.",Other,Acknowledgement Letter/Receipt,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T15:18:53Z,,0,0,09000064849b1603
FDA-2020-P-2317-0002,FDA,FDA-2020-P-2317,Acknowledgment Letter from FDA DMS to Baxter Healthcare Corporation,Other,Acknowledgement Letter/Receipt,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T20:00:11Z,,0,0,09000064849b07aa