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withdrawn,object_id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-1994-P-0028-0047,FDA,FDA-1994-P-0028,"Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2017-12-29T16:45:07Z,,0,0,09000064804fd363
FDA-1994-P-0028-0046,FDA,FDA-1994-P-0028,"Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2017-12-29T16:44:36Z,,0,0,09000064804fd353
FDA-1994-P-0028-0045,FDA,FDA-1994-P-0028,Citizen Petition Denial Response Letter from FDA ORA to Mckenna & Cuneo,Other,Denial of Petition,2017-10-05T04:00:00Z,2017,10,2017-10-05T04:00:00Z,,2017-10-05T13:53:52Z,,0,0,09000064804fd37c
FDA-1994-P-0028-0021,FDA,FDA-1994-P-0028,"Exhibit 1: Letter from FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:21:40Z,,0,0,09000064804fd355
FDA-1994-P-0028-0035,FDA,FDA-1994-P-0028,"Tab F: U. S. District Court for the District of Colorado Marion Merrell Dow, Inc v. Geneva Pharmaceuticals, Inc. re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:57:17Z,,0,0,09000064804fd36c
FDA-1994-P-0028-0028,FDA,FDA-1994-P-0028,"Attachment 1: Citizen Petition from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:31:00Z,,0,0,09000064804fd36a
FDA-1994-P-0028-0038,FDA,FDA-1994-P-0028,"Exhibit 2: Letter from FDA CDER to American Therapeutics, Inc. re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T19:18:01Z,,0,0,09000064804fd360
FDA-1994-P-0028-0023,FDA,FDA-1994-P-0028,"Exhibit 3: U. S. District Court for District of New Jersey Barr Lab vs Otis Bowen et al, re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T16:07:24Z,,0,0,09000064804fd357
FDA-1994-P-0028-0032,FDA,FDA-1994-P-0028,"Tab C: FDA Approved Drug Products with Therapeutic Equivalence Evaluations (13th Ed and 6th Ed) re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:45:33Z,,0,0,09000064804fd366
FDA-1994-P-0028-0031,FDA,FDA-1994-P-0028,"Tab B: FDA Approved Drug Products with Therapeutic Equivalence Evaluations 11th Edition re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:41:44Z,,0,0,09000064804fd367
FDA-1994-P-0028-0029,FDA,FDA-1994-P-0028,"Attachment 2: U. S. District Court for District of Columbia Geneva Pharmaceuticals Inc vs. USA re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:35:38Z,,0,0,09000064804fd369
FDA-1994-P-0028-0022,FDA,FDA-1994-P-0028,"Exhibit 2: Letter from FDA CDER to American Therapeutics, Inc. re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:23:40Z,,0,0,09000064804fd356
FDA-1994-P-0028-0027,FDA,FDA-1994-P-0028,"Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Other,Petition for Reconsideration,2017-10-04T04:00:00Z,2017,10,1994-07-12T04:00:00Z,,2017-10-04T18:25:17Z,,0,0,09000064804fd36b
FDA-1994-P-0028-0033,FDA,FDA-1994-P-0028,"Tab D: Letter From Geneva Pharmaceuticals, Inc. To FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:48:35Z,,0,0,09000064804fd365
FDA-1994-P-0028-0042,FDA,FDA-1994-P-0028,"Attachment 4 U. S. District Court for District Columbia Geneva Pharmaceuticals Inc, v USA re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T19:38:48Z,,0,0,09000064804fd35b
FDA-1994-P-0028-0024,FDA,FDA-1994-P-0028,"Exhibit 4: Letter from FDA CDER to Vitarine Pharmaceuticals, Inc. re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:28:40Z,,0,0,09000064804fd358
FDA-1994-P-0028-0015,FDA,FDA-1994-P-0028,"Tab C:  FDA Approved Drug Products with Therapeutic Equivalence Evaluations (13th Ed and 6th Ed) re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:09:10Z,,0,0,09000064804fd34a
FDA-1994-P-0028-0037,FDA,FDA-1994-P-0028,"Exhibit 1: Letter from FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T19:15:48Z,,0,0,09000064804fd361
FDA-1994-P-0028-0040,FDA,FDA-1994-P-0028,"Exhibit 4: Letter from FDA CDER to Vitarine Pharmaceuticals, Inc. re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T19:28:48Z,,0,0,09000064804fd35d
FDA-1994-P-0028-0039,FDA,FDA-1994-P-0028,"Exhibit 3: U. S. District Court District of New Jersey Barr Lab v. Otis Bowen, et. al., re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T19:22:09Z,,0,0,09000064804fd35f
FDA-1994-P-0028-0036,FDA,FDA-1994-P-0028,"Tab H: Letter from FDA OGC to McKenna & Cuneo re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T19:05:14Z,,0,0,09000064804fd362
FDA-1994-P-0028-0012,FDA,FDA-1994-P-0028,"Attachment 1:  U. S. District Court for District of Columbia Geneva Pharmaceuticals Inc. v. USA re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T16:03:18Z,,0,0,09000064804fd342
FDA-1994-P-0028-0025,FDA,FDA-1994-P-0028,"Attachment 2 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Correction from Geneva Pharmaceuticals, Inc.  (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:52:05Z,,0,0,0900006482b9ba01
FDA-1994-P-0028-0030,FDA,FDA-1994-P-0028,"Tab A: Letter from Geneva Pharmaceuticals to FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:38:39Z,,0,0,09000064804fd368
FDA-1994-P-0028-0017,FDA,FDA-1994-P-0028,"Tab E: Letter from Geneva Pharmaceuticals, Inc. to Marion Merrell Dow re Correction from Geneva Pharmaceuticals, Inc. ( McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:08:55Z,,0,0,09000064804fd34f
FDA-1994-P-0028-0018,FDA,FDA-1994-P-0028,"Tab 2: U. S. District Court D.C. Geneva Pharmaceuticals vs. USA re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:47:18Z,,0,0,09000064804fd351
FDA-1994-P-0028-0034,FDA,FDA-1994-P-0028,"Tab E: Letter from Geneva Pharmaceuticals to Marion Merrell Dow re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T18:52:25Z,,0,0,09000064804fd364
FDA-1994-P-0028-0013,FDA,FDA-1994-P-0028,"Tab A: Letter from Geneva Pharmaceuticals, Inc. to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:09:27Z,,0,0,09000064804fd345
FDA-1994-P-0028-0026,FDA,FDA-1994-P-0028,"Attachment 3: U. S. District Court for District of Columbia Geneva Pharmaceuticals, Inc. vs. USA re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:55:36Z,,0,0,09000064804fd35a
FDA-1994-P-0028-0014,FDA,FDA-1994-P-0028,"Tab B: FDA Approved Drug Products with Therapeutic Equivalence (11th Edition) re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:09:18Z,,0,0,09000064804fd347
FDA-1994-P-0028-0016,FDA,FDA-1994-P-0028,"Tab D: Letter from Geneva Pharmaceuticals, Inc. to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. ( McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:09:02Z,,0,0,09000064804fd34c
FDA-1994-P-0028-0019,FDA,FDA-1994-P-0028,"Tab F: U. S. District Court for District of Columbia Marion Merrell Dow, Inc. vs Geneva Pharmaceuticals, Inc. re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T16:13:00Z,,0,0,09000064804fd352
FDA-1994-P-0028-0041,FDA,FDA-1994-P-0028,"Attachment 3 U. S. District Court for District of Columbia Geneva Pharmaceuticals Inc, V. United States of America re : Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T19:34:20Z,,0,0,09000064804fd35c
FDA-1994-P-0028-0020,FDA,FDA-1994-P-0028,"Tab H: Letter from FDA OCG to McKenna & Cuneo re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-10-04T04:00:00Z,2017,10,,,2017-10-04T15:18:40Z,,0,0,09000064804fd354
FDA-1994-P-0028-0007,FDA,FDA-1994-P-0028,"Exhibit 4: Letter from FDA CDER to Vitarine Pharmaceuticals, Inc. re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-09-29T04:00:00Z,2017,9,,,2017-10-04T16:09:13Z,,0,0,0900006482a1e114
FDA-1994-P-0028-0010,FDA,FDA-1994-P-0028,Acknowledgment Letter from FDA DDM to McKenna & Cuneo,Other,Acknowledgement Letter/Receipt,2017-09-29T04:00:00Z,2017,9,2017-09-29T04:00:00Z,,2017-09-29T18:29:46Z,,0,0,09000064804fd37e
FDA-1994-P-0028-0011,FDA,FDA-1994-P-0028,"Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Other,Correction(s),2017-09-29T04:00:00Z,2017,9,1994-07-12T04:00:00Z,,2017-10-04T14:39:08Z,,0,0,09000064804fd359
FDA-1994-P-0028-0005,FDA,FDA-1994-P-0028,"Exhibit 2: Letter from FDA CDER to American Therapeutics, Inc. re Citizen Petition from Geneva Pharmaceuticals, Inc.  (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-09-29T04:00:00Z,2017,9,,,2017-10-04T16:06:35Z,,0,0,0900006482a1d907
FDA-1994-P-0028-0004,FDA,FDA-1994-P-0028,"Exhibit 1: Letter from FDA CDER re Citizen Petition from Geneva Pharmaceuticals, Inc.  (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-09-29T04:00:00Z,2017,9,,,2017-10-04T16:05:39Z,,0,0,0900006482a1cef1
FDA-1994-P-0028-0008,FDA,FDA-1994-P-0028,"Attachment 2 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Citizen Petition from Geneva Pharmaceuticals, Inc.  (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-09-29T04:00:00Z,2017,9,,,2017-09-29T18:22:27Z,,0,0,0900006482a1def0
FDA-1994-P-0028-0009,FDA,FDA-1994-P-0028,"Attachment 3 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Citizen Petition from Geneva Pharmaceuticals, Inc.  (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-09-29T04:00:00Z,2017,9,,,2017-09-29T18:27:11Z,,0,0,0900006482a1e043
FDA-1994-P-0028-0003,FDA,FDA-1994-P-0028,"Attachment 1 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-09-29T04:00:00Z,2017,9,,,2017-09-29T18:00:13Z,,0,0,0900006482a1c493
FDA-1994-P-0028-0006,FDA,FDA-1994-P-0028,"Exhibit 3: U. S. District Court of New Jersey Barr Lab Inc. v. Otis Bowen et al., re Citizen Petition from Geneva Pharmaceuticals, Inc.  (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-09-29T04:00:00Z,2017,9,,,2017-10-04T15:46:14Z,,0,0,0900006482a1d6d2
FDA-1994-P-0028-0002,FDA,FDA-1994-P-0028,"Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Other,Citizen Petition,2017-09-22T04:00:00Z,2017,9,1994-07-08T04:00:00Z,,2017-10-06T01:04:22Z,,0,0,09000064804fd340
FDA-1994-P-0028-0001,FDA,FDA-1994-P-0028,Acknowledgment Letter from FDA DDM to Mckenna & Cuneo,Other,Acknowledgement Letter/Receipt,1994-07-12T04:00:00Z,1994,7,,,2017-10-07T21:38:33Z,,0,0,09000064804fd339