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withdrawn,object_id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-2013-N-0500-0143,FDA,FDA-2013-N-0500,"03- Reference 02- U.S. Department of Health and Human Services, Food and Drug Administration, “Fiscal Year 2019 Justification of Estimates for Appropriations Committees",Supporting & Related Material,Background Material,2018-12-14T05:00:00Z,2018,12,,,2018-12-14T15:14:01Z,,0,0,09000064839949a4
FDA-2013-N-0500-0141,FDA,FDA-2013-N-0500,01-List of References Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,Supporting & Related Material,Background Material,2018-12-14T05:00:00Z,2018,12,,,2018-12-14T15:12:24Z,,0,0,09000064839949a2
FDA-2013-N-0500-0140,FDA,FDA-2013-N-0500,"Withdrawal of Proposed Rule on Supplemental Applications Proposing
Labeling Changes for Approved Drugs and Biological Products",Proposed Rule,Withdrawal,2018-12-14T05:00:00Z,2018,12,2018-12-14T05:00:00Z,,2018-12-14T14:36:07Z,2018-27098,0,0,09000064839936bc
FDA-2013-N-0500-0142,FDA,FDA-2013-N-0500,"02- Reference 01- Draft guidance for industry, “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn,”",Supporting & Related Material,Background Material,2018-12-14T05:00:00Z,2018,12,,,2018-12-14T15:13:06Z,,0,0,09000064839949a3
FDA-2013-N-0500-0139,FDA,FDA-2013-N-0500,"Attachment 1 Record of Comments from March 13, 2014 re: Supplemental Comment from Washington Legal Foundation",Supporting & Related Material,Background Material,2016-04-26T04:00:00Z,2016,4,,,2016-04-26T18:45:51Z,,0,0,0900006481f8f7d2
FDA-2013-N-0500-0136,FDA,FDA-2013-N-0500,Slide Presentations from the March 27 2015 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Public Meeting Redacted,Other,Presentation,2015-04-29T04:00:00Z,2015,4,2015-04-29T04:00:00Z,,2015-04-29T13:25:10Z,,0,0,0900006481abfea0
FDA-2013-N-0500-0111,FDA,FDA-2013-N-0500,Agenda for March 27 2015 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Public Meeting,Other,Agenda,2015-04-24T04:00:00Z,2015,4,2015-04-24T04:00:00Z,,2015-04-24T20:16:35Z,,0,0,0900006481ab9bdf
FDA-2013-N-0500-0112,FDA,FDA-2013-N-0500,Transcript of March 27 2015 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Public Meeting,Other,Transcript(s),2015-04-24T04:00:00Z,2015,4,2015-04-24T04:00:00Z,,2015-04-24T21:01:09Z,,0,0,0900006481aba131
FDA-2013-N-0500-0105,FDA,FDA-2013-N-0500,"Briefs Submitted in Teva Pharmaceuticals USA, Inc. v. Superior Court of Orange County",Supporting & Related Material,Brief,2015-04-03T04:00:00Z,2015,4,,,2015-04-03T19:17:49Z,,0,0,0900006481a8b7a5
FDA-2013-N-0500-0081,FDA,FDA-2013-N-0500,"Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments;
Reopening of the Comment Period",Proposed Rule,Public Meeting,2015-02-18T05:00:00Z,2015,2,2015-02-18T05:00:00Z,2015-04-28T03:59:59Z,2015-05-07T01:31:29Z,2015-03211,0,0,0900006481a078f5
FDA-2013-N-0500-0082,FDA,FDA-2013-N-0500,"Reference 1 - Joint GPhA PhRMA Letter to Dr Hamburg re Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments;
Reopening of the Comment Period",Supporting & Related Material,Background Material,2015-02-18T05:00:00Z,2015,2,,,2015-02-18T18:01:50Z,,0,0,0900006481a0854b
FDA-2013-N-0500-0080,FDA,FDA-2013-N-0500,"Memorandum of Meeting with GPhA (September 8, 2014)",Other,Memorandum,2014-12-17T05:00:00Z,2014,12,2014-12-17T05:00:00Z,,2014-12-19T20:58:41Z,,0,0,090000648197f44a
FDA-2013-N-0500-0079,FDA,FDA-2013-N-0500,Supplement from the Generic Pharmaceutical Association,Other,Supplement (SUP),2014-07-18T04:00:00Z,2014,7,2014-07-18T04:00:00Z,,2014-07-18T13:56:52Z,,0,0,0900006481775a8b
FDA-2013-N-0500-0078,FDA,FDA-2013-N-0500,"Attachment 3 Revised Virilon Package Insert with Changes Highlighted Supplement from Star Pharmaceuticals, Inc.",Supporting & Related Material,Background Material,2014-06-05T04:00:00Z,2014,6,,,2014-06-16T20:38:52Z,,0,0,090000648171fbc5
FDA-2013-N-0500-0075,FDA,FDA-2013-N-0500,"Supplement from Star Pharmaceuticals, Inc.",Other,Supplement (SUP),2014-06-05T04:00:00Z,2014,6,2014-06-05T04:00:00Z,,2014-06-05T19:03:19Z,,0,0,090000648171fd33
FDA-2013-N-0500-0077,FDA,FDA-2013-N-0500,"Attachment 2 Revised Virilon Package Insert re Supplement from Star Pharmaceuticals, Inc.",Supporting & Related Material,Background Material,2014-06-05T04:00:00Z,2014,6,,,2014-10-24T19:16:16Z,,0,0,090000648171fbc4
FDA-2013-N-0500-0076,FDA,FDA-2013-N-0500,"Attachment 1 Virilon Drug Listing re Supplement from Star Pharmaceuticals, Inc.",Supporting & Related Material,Background Material,2014-06-05T04:00:00Z,2014,6,,,2014-10-24T19:15:34Z,,0,0,090000648171fad3
FDA-2013-N-0500-0010,FDA,FDA-2013-N-0500,Request for Extension from Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA),Other,Request for Extension,2014-02-10T05:00:00Z,2014,2,2014-02-10T05:00:00Z,,2016-10-31T13:21:42Z,,0,0,09000064814c6d0a
FDA-2013-N-0500-0009,FDA,FDA-2013-N-0500,Request for Extension from Mylan,Other,Request for Extension,2014-02-10T05:00:00Z,2014,2,2014-02-10T05:00:00Z,,2016-10-31T13:21:42Z,,0,0,09000064814c5e12
FDA-2013-N-0500-0011,FDA,FDA-2013-N-0500,Request for Extension from Perrigo,Other,Request for Extension,2014-02-10T05:00:00Z,2014,2,2014-02-10T05:00:00Z,,2016-10-31T13:21:44Z,,0,0,09000064814ca396
FDA-2013-N-0500-0008,FDA,FDA-2013-N-0500,Request for Extension from Academy of Managed Care Pharmacy (AMCP) et al,Other,Request for Extension,2014-02-10T05:00:00Z,2014,2,,,2016-10-31T13:21:41Z,,0,0,09000064814c4f5c
FDA-2013-N-0500-0007,FDA,FDA-2013-N-0500,Request for Extension from Perrigo,Other,Request for Extension,2014-02-10T05:00:00Z,2014,2,2014-02-10T05:00:00Z,,2016-10-31T13:21:40Z,,0,0,09000064814b4789
FDA-2013-N-0500-0006,FDA,FDA-2013-N-0500,Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period,Proposed Rule,Extension of Comment Period,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,2014-03-14T03:59:59Z,2014-04-10T01:02:03Z,2013-30881,0,0,09000064814debad
FDA-2013-N-0500-0005,FDA,FDA-2013-N-0500,"OMB Review Proposed Rule re Executive Order 12866, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 11-13-2013 - Memorandum",Other,Memorandum,2013-12-13T05:00:00Z,2013,12,2013-12-13T05:00:00Z,,2013-12-13T16:08:47Z,,0,0,09000064814bc8a9
FDA-2013-N-0500-0004,FDA,FDA-2013-N-0500,Generic Pharmaceutical Association (GPhA) - Request for Extension of Comment Period,Other,Request for Extension,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,,2013-12-04T20:09:50Z,,0,0,090000648149a218
FDA-2013-N-0500-0002,FDA,FDA-2013-N-0500,"OMB Review Proposed Rule re Executive Order 12866, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 11-13-2013 - Memorandum",Other,,2013-11-21T00:00:00Z,2013,11,,,2013-11-25T14:34:53Z,,0,1,090000648148e9e1
FDA-2013-N-0500-0001,FDA,FDA-2013-N-0500,Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2013-11-13T05:00:00Z,2013,11,2013-11-13T05:00:00Z,2014-01-14T04:59:59Z,2016-04-26T19:00:32Z,2013-26799,0,0,090000648147a982