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withdrawn,object_id FDA-2016-N-0002-0048,FDA,FDA-2016-N-0002,"Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction",Notice,Correction,2018-02-13T05:00:00Z,2018,2,2018-02-13T05:00:00Z,,2018-02-13T15:05:16Z,2018-02926,0,0,0900006482f279da FDA-2016-N-0002-0047,FDA,FDA-2016-N-0002,"Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction",Notice,Correction,2017-07-18T04:00:00Z,2017,7,2017-07-18T04:00:00Z,,2017-07-18T14:50:54Z,2017-15003,0,0,090000648293b5a7 FDA-2016-N-0002-0041,FDA,FDA-2016-N-0002,FOI Summary oA 200-589 approved December 21 2016,Supporting & Related Material,Background Material,2017-03-01T05:00:00Z,2017,3,,,2017-03-01T17:59:40Z,,0,0,09000064824e4a20 FDA-2016-N-0002-0042,FDA,FDA-2016-N-0002,FOI Summary oN 141-473 approved December 16 2016,Supporting & Related Material,Background Material,2017-03-01T05:00:00Z,2017,3,,,2017-03-01T18:00:21Z,,0,0,09000064824e4a21 FDA-2016-N-0002-0043,FDA,FDA-2016-N-0002,FOI Summary oN 141-474 approved November 10 2016,Supporting & Related Material,Background Material,2017-03-01T05:00:00Z,2017,3,,,2017-03-01T18:00:55Z,,0,0,09000064824e4dd9 FDA-2016-N-0002-0045,FDA,FDA-2016-N-0002,"FOI Summary sN 141-443, approved November 16, 2016",Supporting & Related Material,Background Material,2017-03-01T05:00:00Z,2017,3,,,2017-03-01T18:02:03Z,,0,0,09000064824e4ddb FDA-2016-N-0002-0044,FDA,FDA-2016-N-0002,FOI Summary oN 141-475 approved December 29 2016,Supporting & Related Material,Background Material,2017-03-01T05:00:00Z,2017,3,,,2017-03-01T18:01:29Z,,0,0,09000064824e4dda FDA-2016-N-0002-0046,FDA,FDA-2016-N-0002,FOI Summary sN 141-452 approved December 12 2016,Supporting & Related Material,Background Material,2017-03-01T05:00:00Z,2017,3,,,2017-03-01T18:02:38Z,,0,0,09000064824e4ddc FDA-2016-N-0002-0040,FDA,FDA-2016-N-0002,New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name,Rule,Final Rule,2017-03-01T05:00:00Z,2017,3,2017-03-01T05:00:00Z,,2017-03-01T15:12:02Z,2017-03930,0,0,09000064824e380d FDA-2016-N-0002-0037,FDA,FDA-2016-N-0002,New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications,Rule,Withdrawal,2017-02-24T05:00:00Z,2017,2,2017-02-24T05:00:00Z,,2017-02-24T16:18:39Z,2017-03595,0,0,09000064824d99cf FDA-2016-N-0002-0038,FDA,FDA-2016-N-0002,New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application,Rule,Withdrawal,2017-02-24T05:00:00Z,2017,2,2017-02-24T05:00:00Z,,2017-02-24T16:23:09Z,2017-03678,0,0,09000064824d99d6 FDA-2016-N-0002-0039,FDA,FDA-2016-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor’s Address,Rule,Final Rule,2017-02-24T05:00:00Z,2017,2,2017-02-24T05:00:00Z,,2017-02-24T16:27:30Z,2017-03677,0,0,09000064824d9ac7 FDA-2016-N-0002-0036,FDA,FDA-2016-N-0002,"New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications",Rule,Final Rule,2017-02-24T05:00:00Z,2017,2,2017-02-24T05:00:00Z,,2017-02-24T16:12:09Z,2017-03596,0,0,09000064824d9933 FDA-2016-N-0002-0035,FDA,FDA-2016-N-0002,"Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications",Notice,Withdrawal,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T15:02:22Z,2016-31625,0,0,090000648243d2a9 FDA-2016-N-0002-0034,FDA,FDA-2016-N-0002,"Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications",Rule,Final Rule,2016-12-27T05:00:00Z,2016,12,2016-12-27T05:00:00Z,,2016-12-27T15:20:22Z,2016-31084,0,0,0900006482437617 FDA-2016-N-0002-0033,FDA,FDA-2016-N-0002,New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications,Rule,Withdrawal,2016-12-27T05:00:00Z,2016,12,2016-12-27T05:00:00Z,,2016-12-27T14:40:37Z,2016-31082,0,0,09000064824374ac FDA-2016-N-0002-0032,FDA,FDA-2016-N-0002,"New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications",Rule,Final Rule,2016-12-27T05:00:00Z,2016,12,2016-12-27T05:00:00Z,,2016-12-27T13:37:48Z,2016-31083,0,0,090000648243727b FDA-2016-N-0002-0031,FDA,FDA-2016-N-0002,"Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications",Notice,Withdrawal,2016-10-04T04:00:00Z,2016,10,2016-10-04T04:00:00Z,,2016-10-04T16:14:57Z,2016-23893,0,0,0900006482291438 FDA-2016-N-0002-0030,FDA,FDA-2016-N-0002,New Animal Drugs: Approval of New Animal Drug Applications; Change of Sponsor's Address,Rule,Final Rule,2016-09-30T04:00:00Z,2016,9,2016-09-30T04:00:00Z,,2016-09-30T13:43:41Z,2016-23230,0,0,0900006482284ad3 FDA-2016-N-0002-0029,FDA,FDA-2016-N-0002,"New Animal Drugs for Use in Animal Feeds: Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine",Rule,Final Rule,2016-09-14T04:00:00Z,2016,9,2016-09-14T04:00:00Z,,2016-09-14T13:59:59Z,2016-21985,0,0,090000648220a1e1 FDA-2016-N-0002-0028,FDA,FDA-2016-N-0002,"Withdrawal of Approval of Part of a New Animal Drug Application; Chlortetracycline, Procaine Penicillin, and Sulfamethazine",Notice,Withdrawal,2016-09-14T04:00:00Z,2016,9,2016-09-14T04:00:00Z,,2016-09-14T13:36:10Z,2016-21984,0,0,0900006482209c71 FDA-2016-N-0002-0019,FDA,FDA-2016-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address",Rule,Correction,2016-08-29T04:00:00Z,2016,8,2016-08-29T04:00:00Z,,2016-08-29T15:36:17Z,2016-19914,0,0,09000064821a8156 FDA-2016-N-0002-0027,FDA,FDA-2016-N-0002,"FOI Summary oA 200-596, approved May 24, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T16:11:19Z,,0,0,09000064821a95b5 FDA-2016-N-0002-0026,FDA,FDA-2016-N-0002,"FOI Summary oN 141-463, approved May 17, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T16:08:53Z,,0,0,09000064821a95b4 FDA-2016-N-0002-0020,FDA,FDA-2016-N-0002,"EA oN 141-439, approved May 2, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T15:55:41Z,,0,0,09000064821a95ae FDA-2016-N-0002-0018,FDA,FDA-2016-N-0002,New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application,Rule,Withdrawal,2016-08-29T04:00:00Z,2016,8,2016-08-29T04:00:00Z,,2016-08-29T15:26:57Z,2016-19915,0,0,09000064821a7b65 FDA-2016-N-0002-0022,FDA,FDA-2016-N-0002,"FOI Summary oA 200-587, approved June 20, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T15:54:56Z,,0,0,09000064821a95b0 FDA-2016-N-0002-0021,FDA,FDA-2016-N-0002,"FOI Summary oA 200-536, approved May 17, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T15:56:15Z,,0,0,09000064821a95af FDA-2016-N-0002-0024,FDA,FDA-2016-N-0002,"FOI Summary oN 141-439, approved May 2, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T16:04:28Z,,0,0,09000064821a95b2 FDA-2016-N-0002-0025,FDA,FDA-2016-N-0002,"FOI Summary oN 141-457, approved May 16, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T16:06:08Z,,0,0,09000064821a95b3 FDA-2016-N-0002-0023,FDA,FDA-2016-N-0002,"FOI Summary oA 200-596, approved May 24, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Supporting & Related Material,Background Material,2016-08-29T04:00:00Z,2016,8,,,2016-08-29T16:03:00Z,,0,0,09000064821a95b1 FDA-2016-N-0002-0017,FDA,FDA-2016-N-0002,Finding of No Significant Impact (FONSI) for IMRESTOR (pegbovigrastim injection) in Dairy Cattle,Supporting & Related Material,Background Material,2016-06-08T04:00:00Z,2016,6,,,2016-06-13T21:06:34Z,,0,0,0900006482021116 FDA-2016-N-0002-0012,FDA,FDA-2016-N-0002,New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship,Rule,Final Rule,2016-06-08T04:00:00Z,2016,6,2016-06-08T04:00:00Z,,2016-06-08T14:03:11Z,2016-13517,0,0,090000648201e0ff FDA-2016-N-0002-0014,FDA,FDA-2016-N-0002,FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-392 IMRESTOR,Supporting & Related Material,Background Material,2016-06-08T04:00:00Z,2016,6,,,2016-06-13T21:06:14Z,,0,0,0900006482021113 FDA-2016-N-0002-0013,FDA,FDA-2016-N-0002,Environmental Assessment of PEGylated bovine granulocyte colony stimulating factor (PEG bG-CSF) for Dairy Cows (USA),Supporting & Related Material,Background Material,2016-06-08T04:00:00Z,2016,6,,,2016-06-13T21:06:06Z,,0,0,0900006482021112 FDA-2016-N-0002-0015,FDA,FDA-2016-N-0002,FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-455 GALLIPRANT,Supporting & Related Material,Background Material,2016-06-08T04:00:00Z,2016,6,,,2016-06-13T21:06:21Z,,0,0,0900006482021114 FDA-2016-N-0002-0016,FDA,FDA-2016-N-0002,FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-460 AIVLOSIN 17% Tylvalosin Type A Medicated Article Swine,Supporting & Related Material,Background Material,2016-06-08T04:00:00Z,2016,6,,,2016-06-13T21:06:27Z,,0,0,0900006482021115 FDA-2016-N-0002-0011,FDA,FDA-2016-N-0002,"New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application",Rule,Withdrawal,2016-06-08T04:00:00Z,2016,6,2016-06-08T04:00:00Z,,2016-06-08T13:29:59Z,2016-13518,0,0,090000648201df5b FDA-2016-N-0002-0010,FDA,FDA-2016-N-0002,New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship; Correction,Rule,Final Rule,2016-04-28T04:00:00Z,2016,4,2016-04-28T04:00:00Z,,2016-04-28T16:16:35Z,2016-09865,0,0,0900006481f94e7f FDA-2016-N-0002-0007,FDA,FDA-2016-N-0002,FOI Summary NADA 141-263 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:45:37Z,,0,0,0900006481f71386 FDA-2016-N-0002-0001,FDA,FDA-2016-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Rule,Correction,2016-04-18T04:00:00Z,2016,4,2016-04-18T04:00:00Z,,2016-04-18T16:03:25Z,2016-08827,0,0,0900006481f705dc FDA-2016-N-0002-0009,FDA,FDA-2016-N-0002,FONSI 141-449 SAFE-GUARD AQUASOL (fenbendazole oral suspension) in Swine except for nursing piglets re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:45:55Z,,0,0,0900006481f7139d FDA-2016-N-0002-0004,FDA,FDA-2016-N-0002,FOI Summary NADA 141-444 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:45:11Z,,0,0,0900006481f710c4 FDA-2016-N-0002-0005,FDA,FDA-2016-N-0002,FOI Summary NADA 141-448 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:45:22Z,,0,0,0900006481f710c5 FDA-2016-N-0002-0008,FDA,FDA-2016-N-0002,FOI Summary NADA 141-449 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:45:46Z,,0,0,0900006481f71389 FDA-2016-N-0002-0002,FDA,FDA-2016-N-0002,Environmental Assessment re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:44:59Z,,0,0,0900006481f710be FDA-2016-N-0002-0006,FDA,FDA-2016-N-0002,FOI Summary NADA 141-452 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:45:29Z,,0,0,0900006481f71323 FDA-2016-N-0002-0003,FDA,FDA-2016-N-0002,FOI Original Abbreviated New Animal Drug Application re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Supporting & Related Material,Background Material,2016-04-18T04:00:00Z,2016,4,,,2016-05-05T22:44:52Z,,0,0,0900006481f710c3