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withdrawn,object_id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-1977-N-0356-0019,FDA,FDA-1977-N-0356,Letter from K & L Gates to FDA CDER,Other,Letter(s),2020-07-21T04:00:00Z,2020,7,2020-07-21T04:00:00Z,,2020-07-21T14:17:11Z,,0,0,090000648478c167
FDA-1977-N-0356-0022,FDA,FDA-1977-N-0356,"Letter from Lumara Health, AMAG Pharmaceuticals",Other,Letter(s),2020-07-21T04:00:00Z,2020,7,2020-07-21T04:00:00Z,,2020-07-21T14:23:49Z,,0,0,090000648478cf79
FDA-1977-N-0356-0020,FDA,FDA-1977-N-0356,Letter from K & L Gates to FDA CDER,Other,Letter(s),2020-07-21T04:00:00Z,2020,7,2020-07-21T04:00:00Z,,2020-07-21T14:19:16Z,,0,0,090000648478c168
FDA-1977-N-0356-0021,FDA,FDA-1977-N-0356,Letter from KV Pharmaceutical to FDA CDER,Other,Letter(s),2020-07-21T04:00:00Z,2020,7,2020-07-21T04:00:00Z,,2020-07-21T14:21:33Z,,0,0,090000648478c169
FDA-1977-N-0356-0018,FDA,FDA-1977-N-0356,"Letter from Time-Cap Labs, Inc. (King & Spalding) to FDA",Other,Letter(s),2020-01-13T05:00:00Z,2020,1,2020-01-13T05:00:00Z,,2020-01-13T21:07:32Z,,0,0,090000648428a8cd
FDA-1977-N-0356-0017,FDA,FDA-1977-N-0356,FDA to Time-Cap,Other,Letter(s),2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,,2019-12-16T15:57:55Z,,0,0,09000064842138ca
FDA-1977-N-0356-0016,FDA,FDA-1977-N-0356,"Drugs for Human Use; Drug Efficacy Study Implementation; Nitroglycerin
Transdermal Systems; Withdrawal of Hearing Request; Withdrawal of
Applications; Final Resolution of Hearing Requests Regarding
Transdermal Systems Under Docket",Notice,Announcement,2015-11-16T05:00:00Z,2015,11,2015-11-16T05:00:00Z,,2024-11-07T23:35:36Z,2015-28853,1,0,0900006481d488ba
FDA-1977-N-0356-0015,FDA,FDA-1977-N-0356,Letter from FDA CDER to Sandoz Inc.,Other,Letter(s),2015-10-22T04:00:00Z,2015,10,2015-10-22T04:00:00Z,,2015-10-22T18:51:06Z,,0,0,0900006481ce26c2
FDA-1977-N-0356-0012,FDA,FDA-1977-N-0356,Correspondence from Zuckerman Spaeder LLP to FDA CDER,Other,Correspondence,2015-04-09T04:00:00Z,2015,4,2015-04-09T04:00:00Z,,2015-04-09T17:09:18Z,,0,0,09000064810080e6
FDA-1977-N-0356-0013,FDA,FDA-1977-N-0356,Request for Hearing from Lumara Health Inc,Other,Request for Hearing,2015-04-09T04:00:00Z,2015,4,2015-04-09T04:00:00Z,,2015-05-13T14:52:12Z,,0,0,0900006481a98273
FDA-1977-N-0356-0014,FDA,FDA-1977-N-0356,Withdrawal of Hearing Request from Lumara Health Inc,Other,Withdrawal,2015-04-09T04:00:00Z,2015,4,2015-04-09T04:00:00Z,,2015-05-13T14:51:10Z,,0,0,0900006481a98274
FDA-1977-N-0356-0008,FDA,FDA-1977-N-0356,"FDA/CDER Letter to Time-Cap Labs. Inc. - [King & Spalding, LLP] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:32:35Z,,1,0,0900006480f090b0
FDA-1977-N-0356-0007,FDA,FDA-1977-N-0356,"FDA/CDER Letter to Schwarz Pharma, Inc., [Kleinfeld, Kaplan & Becker, LLP] - Letter - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:58:03Z,,0,0,0900006480f090ac
FDA-1977-N-0356-0009,FDA,FDA-1977-N-0356,FDA/CDER Letter to Eon Labs Manufacturing. Inc. - [K&L Gates] - Letter,Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:25:38Z,,0,0,0900006480f090ca
FDA-1977-N-0356-0005,FDA,FDA-1977-N-0356,FDA/CDER Letter to KV Pharmaceutical Company - [ Zuckerman Spaeder LLP] - Letter,Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-07T22:19:01Z,,1,0,0900006480f0909b
FDA-1977-N-0356-0010,FDA,FDA-1977-N-0356,"FDA/CDER Letter to Hereon Laboratories - [ Kleinfeld, Kaplan & Becker, LLP] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2011-08-30T19:58:59Z,,0,0,0900006480f090ce
FDA-1977-N-0356-0011,FDA,FDA-1977-N-0356,FDA/CDER Letter to Eon Labs Manufacturing. Inc. - [K&L Gates] - Letter,Other,Letter(s),2011-08-30T04:00:00Z,2011,8,,,2011-08-30T19:31:19Z,,0,0,0900006480f090ea
FDA-1977-N-0356-0006,FDA,FDA-1977-N-0356,"FDA/CDER Letter to KV Pharmaceutical Company - [Buc & Beardsley, LLP] - Letter",Other,Letter(s),2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2024-11-12T05:02:48Z,,1,0,0900006480f090aa
FDA-1977-N-0356-0002,FDA,FDA-1977-N-0356,"Letter from King & Spalding on behalf of Time-Cap Labs, Inc. to FDA",Other,Letter(s),2011-04-06T04:00:00Z,2011,4,2011-04-06T04:00:00Z,,2019-05-06T16:43:31Z,,0,0,0900006480c10fc9
FDA-1977-N-0356-0004,FDA,FDA-1977-N-0356,"Attachment 2- Letter from King & Spalding, LLP to FDA, dated May 17, 1999 - [Time-Cap Labs, Inc. (King & Spalding, LLP) - Letter]",Supporting & Related Material,LET-Letter (Supporting and Related Material),2011-04-06T04:00:00Z,2011,4,,,2011-04-06T16:45:48Z,,0,0,0900006480c10fcd
FDA-1977-N-0356-0003,FDA,FDA-1977-N-0356,"Attachment 1 - FDA/CDER Response to King & Spalding, LLP, dated January 10, 2011 - [Time-Cap Labs, Inc. (King & Spalding, LLP) - Letter]",Supporting & Related Material,LET-Letter (Supporting and Related Material),2011-04-06T04:00:00Z,2011,4,,,2011-04-06T16:45:47Z,,0,0,0900006480c10fca
FDA-1977-N-0356-0001,FDA,FDA-1977-N-0356,Certain Single-Entity Coronary Vasodilators Containing Controlled-Release Nitroglycerin; Opportunity for a Hearing,Notice,Notice of Opportunity of Hearing,2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,1999-06-22T03:59:59Z,2019-05-06T16:30:57Z,99-9770,0,0,09000064805ee900