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withdrawn,object_id FDA-1998-N-0051-0189,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:17Z,,0,0,09000064859519ea FDA-1998-N-0051-0196,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:55Z,,0,0,0900006485951ebd FDA-1998-N-0051-0193,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:39Z,,0,0,0900006485951eb7 FDA-1998-N-0051-0190,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:23Z,,0,0,09000064859519ec FDA-1998-N-0051-0191,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:28Z,,0,0,0900006485951eb3 FDA-1998-N-0051-0197,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:42:00Z,,0,0,0900006485951ebf FDA-1998-N-0051-0188,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:08Z,,0,0,0900006485951d11 FDA-1998-N-0051-0195,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:49Z,,0,0,0900006485951ebb FDA-1998-N-0051-0194,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:44Z,,0,0,0900006485951eb9 FDA-1998-N-0051-0192,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:41:33Z,,0,0,0900006485951eb5 FDA-1998-N-0051-0198,FDA,FDA-1998-N-0051,Exemption Application from St. Mary's Medical Park Pharmacy,Other,Application,2023-04-17T04:00:00Z,2023,4,2023-04-17T04:00:00Z,,2023-04-17T21:42:05Z,,0,0,0900006485951ec1 FDA-1998-N-0051-0187,FDA,FDA-1998-N-0051,"Request for Exemption 21 CFR 201.66 (OTC) from Liberty Pharmaceuticals, Inc.",Other,Request,2019-10-10T04:00:00Z,2019,10,2019-10-10T04:00:00Z,,2019-10-10T14:46:48Z,,0,0,090000648407a6d3 FDA-1998-N-0051-0186,FDA,FDA-1998-N-0051,FDA Response_Application for Labeling Exemption_121817,Other,Response(s),2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,,2017-12-19T22:08:02Z,,0,0,0900006482d3d1f9 FDA-1998-N-0051-0185,FDA,FDA-1998-N-0051,"Exemption Application from Modern Aids, Inc",Other,Petitions for Exemption,2017-06-30T04:00:00Z,2017,6,2017-06-30T04:00:00Z,,2017-06-30T15:41:32Z,,0,0,09000064824ea1bf FDA-1998-N-0051-0184,FDA,FDA-1998-N-0051,Exemption Denial Letter from FDA CDER to Carma Laboratories Inc.,Other,Denial,2017-03-07T05:00:00Z,2017,3,2017-03-07T05:00:00Z,,2017-03-07T15:27:02Z,,0,0,09000064824f2aec FDA-1998-N-0051-0183,FDA,FDA-1998-N-0051,Letter from FDA CDER to Germ Guards Inc.,Other,Letter(s),2017-01-09T05:00:00Z,2017,1,2017-01-09T05:00:00Z,,2017-01-09T21:19:20Z,,0,0,0900006482455298 FDA-1998-N-0051-0182,FDA,FDA-1998-N-0051,Request for Exemption from Germ Guards Inc.,Other,Request,2016-10-18T04:00:00Z,2016,10,2016-10-18T04:00:00Z,,2016-10-18T17:56:45Z,,0,0,09000064823125b4 FDA-1998-N-0051-0181,FDA,FDA-1998-N-0051,"Application for Exemption from F & F Foods, Inc.",Other,Application,2016-08-24T04:00:00Z,2016,8,2016-08-24T04:00:00Z,,2016-08-24T14:50:12Z,,0,0,090000648064532a FDA-1998-N-0051-0179,FDA,FDA-1998-N-0051,"Response from FDA CDER to Kleinfeld, Kaplan and Becker",Other,Answer,2016-08-24T04:00:00Z,2016,8,2016-08-24T04:00:00Z,,2016-08-24T14:25:56Z,,0,0,090000648056e938 FDA-1998-N-0051-0178,FDA,FDA-1998-N-0051,"Attachment 2 Amendment from Hyman, Phelps and McNamara (Block Drug Company Inc.) re: Application for Exemption from Kleinfeld, Kaplan and Becker (GlaxoSmithKline)",Supporting & Related Material,Background Material,2016-08-24T04:00:00Z,2016,8,,,2016-08-24T14:16:07Z,,0,0,090000648056e936 FDA-1998-N-0051-0176,FDA,FDA-1998-N-0051,"Application for Exemption from Kleinfeld, Kaplan and Becker (GlaxoSmithKline)",Other,Application,2016-08-24T04:00:00Z,2016,8,2016-08-24T04:00:00Z,,2016-08-24T13:58:35Z,,0,0,090000648056e937 FDA-1998-N-0051-0177,FDA,FDA-1998-N-0051,"Attachment 1 BC Labels re: Application for Exemption from Kleinfeld, Kaplan and Becker (GlaxoSmithKline)",Supporting & Related Material,Background Material,2016-08-24T04:00:00Z,2016,8,,,2016-08-24T14:01:01Z,,0,0,090000648056e935 FDA-1998-N-0051-0173,FDA,FDA-1998-N-0051,"Letter from Kleinfeld, Kaplan and Becker to FDA CDER",Other,Letter(s),2016-08-22T04:00:00Z,2016,8,2016-08-22T04:00:00Z,,2016-08-22T19:10:51Z,,0,0,090000648056e934 FDA-1998-N-0051-0167,FDA,FDA-1998-N-0051,"Attachment 2 Ricola Label re: Application for Exemption from Arent Fox (Ricola, Inc.)",Supporting & Related Material,Background Material,2016-08-22T04:00:00Z,2016,8,,,2016-08-22T15:19:33Z,,0,0,090000648056e928 FDA-1998-N-0051-0175,FDA,FDA-1998-N-0051,"Response from FDA CDER to LNK International, Inc.",Other,Answer,2016-08-22T04:00:00Z,2016,8,2016-08-22T04:00:00Z,,2016-08-22T19:24:09Z,,0,0,090000648056e939 FDA-1998-N-0051-0164,FDA,FDA-1998-N-0051,Response from FDA CDER to Becton Dickinson and Company,Other,Answer,2016-08-22T04:00:00Z,2016,8,2016-08-22T04:00:00Z,,2016-08-22T14:17:45Z,,0,0,090000648056e92a FDA-1998-N-0051-0166,FDA,FDA-1998-N-0051,"Attachment 1 Ricola Label re: Application for Exemption from Arent Fox (Ricola, Inc.)",Supporting & Related Material,Background Material,2016-08-22T04:00:00Z,2016,8,,,2016-08-22T15:16:43Z,,0,0,090000648056e929 FDA-1998-N-0051-0169,FDA,FDA-1998-N-0051,"Exhibit A Comment from CTFA on FRN 62FR9024 (February 27, 1997) re: Comment from Cosmetic, Toiletry, and Fragrance Association (CTFA)",Supporting & Related Material,Background Material,2016-08-22T04:00:00Z,2016,8,,,2016-08-22T15:27:33Z,,0,0,090000648056e92c FDA-1998-N-0051-0165,FDA,FDA-1998-N-0051,"Application for Exemption from Arent Fox (Ricola, Inc.)",Other,Application,2016-08-22T04:00:00Z,2016,8,2016-08-22T04:00:00Z,,2016-08-22T15:11:01Z,,0,0,090000648056e927 FDA-1998-N-0051-0174,FDA,FDA-1998-N-0051,"Response from FDA CDER to Arent Fox Kintner Plotkin & Kahn, PLLC (Ricola USA Inc.)",Other,Answer,2016-08-22T04:00:00Z,2016,8,2016-08-22T04:00:00Z,,2016-08-22T19:17:38Z,,0,0,090000648056e932 FDA-1998-N-0051-0155,FDA,FDA-1998-N-0051,Response from FDA CDER to Pfizer Consumer Healthcare,Other,Answer,2016-08-19T04:00:00Z,2016,8,2016-08-19T04:00:00Z,,2016-08-19T15:56:26Z,,0,0,090000648056e907 FDA-1998-N-0051-0158,FDA,FDA-1998-N-0051,"Application for Exemption from LNK International, Inc.",Other,Application,2016-08-19T04:00:00Z,2016,8,2016-08-19T04:00:00Z,,2016-08-19T16:32:25Z,,0,0,090000648056e926 FDA-1998-N-0051-0156,FDA,FDA-1998-N-0051,Letter from FDA CDER to Hyman Phelps & McNamara,Other,Answer,2016-08-19T04:00:00Z,2016,8,2016-08-19T04:00:00Z,,2016-08-19T16:05:28Z,,0,0,090000648056e908 FDA-1998-N-0051-0153,FDA,FDA-1998-N-0051,"Letter from FDA CDER to Zee Medical, Inc.",Other,Letter(s),2016-08-19T04:00:00Z,2016,8,2016-08-19T04:00:00Z,,2016-08-19T15:11:59Z,,0,0,090000648056e8fb FDA-1998-N-0051-0160,FDA,FDA-1998-N-0051,"Attachment 2 Items 7-8 Decongestant Labels re: Application for Exemption from LNK International, Inc.",Supporting & Related Material,Background Material,2016-08-19T04:00:00Z,2016,8,,,2016-08-19T16:50:15Z,,0,0,090000648056e90f FDA-1998-N-0051-0152,FDA,FDA-1998-N-0051,Withdrawal from L. Perrigo Company,Other,Withdrawal,2016-08-19T04:00:00Z,2016,8,2016-08-19T04:00:00Z,,2016-08-19T14:16:51Z,,0,0,090000648056e8fa FDA-1998-N-0051-0159,FDA,FDA-1998-N-0051,"Attachment 1 Items 1-6 Antacid Labels re: Application for Exemption from LNK International, Inc.",Supporting & Related Material,Background Material,2016-08-19T04:00:00Z,2016,8,,,2016-08-19T16:43:42Z,,0,0,090000648056e90b FDA-1998-N-0051-0154,FDA,FDA-1998-N-0051,Letter from FDA CDER to L. Perrigo Company,Other,Letter(s),2016-08-19T04:00:00Z,2016,8,2016-08-19T04:00:00Z,,2016-08-19T15:15:36Z,,0,0,090000648056e8fc FDA-1998-N-0051-0162,FDA,FDA-1998-N-0051,"Attachment 4 Items 10-12 Decongestant and Antihistamine Labels re: Application for Exemption from LNK International, Inc.",Supporting & Related Material,Background Material,2016-08-19T04:00:00Z,2016,8,,,2016-08-19T17:07:34Z,,0,0,090000648056e911 FDA-1998-N-0051-0161,FDA,FDA-1998-N-0051,"Attachment 3 Item 9 Antihistamine Labels re: Application for Exemption from LNK International, Inc.",Supporting & Related Material,Background Material,2016-08-19T04:00:00Z,2016,8,,,2016-08-19T16:57:48Z,,0,0,090000648056e910 FDA-1998-N-0051-0163,FDA,FDA-1998-N-0051,"Attachment 5 Items 13-19 Decongestant and Antihistamine Labels re: Application for Exemption from LNK International, Inc.",Supporting & Related Material,Background Material,2016-08-19T04:00:00Z,2016,8,,,2016-08-19T17:34:35Z,,0,0,090000648056e913 FDA-1998-N-0051-0151,FDA,FDA-1998-N-0051,Letter from FDA CDER to L. Perrigo Company,Other,Letter(s),2016-08-19T04:00:00Z,2016,8,2016-08-19T04:00:00Z,,2016-08-19T14:13:35Z,,0,0,090000648056e8f9 FDA-1998-N-0051-0142,FDA,FDA-1998-N-0051,Application for Exemption from McNeil Consumer Healthcare,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T18:26:08Z,,0,0,090000648056e8ec FDA-1998-N-0051-0136,FDA,FDA-1998-N-0051,Application for Exemption from McNeil Consumer Healthcare,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T16:20:48Z,,0,0,090000648056e8e3 FDA-1998-N-0051-0150,FDA,FDA-1998-N-0051,Attachment 2 Imodium Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T19:23:45Z,,0,0,090000648056e8f4 FDA-1998-N-0051-0130,FDA,FDA-1998-N-0051,"Response from FDA CDER to National Reye's Syndrome Foundation, Inc.",Other,Letter(s),2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T15:35:14Z,,0,0,090000648056e8db FDA-1998-N-0051-0124,FDA,FDA-1998-N-0051,Application for Exemption from McNeil Consumer Healthcare,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T14:25:38Z,,0,0,090000648056e8d6 FDA-1998-N-0051-0145,FDA,FDA-1998-N-0051,Application for Exemption from McNeil Consumer Healthcare,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T18:43:34Z,,0,0,090000648056e8ef FDA-1998-N-0051-0118,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T13:47:16Z,,0,0,090000648056e8d0 FDA-1998-N-0051-0144,FDA,FDA-1998-N-0051,Attachment 2 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T18:30:31Z,,0,0,090000648056e8ee FDA-1998-N-0051-0134,FDA,FDA-1998-N-0051,Withdrawal from L Perrigo Company,Other,Withdrawal,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T15:59:56Z,,0,0,090000648056e8e1 FDA-1998-N-0051-0119,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T13:51:25Z,,0,0,090000648056e8d1 FDA-1998-N-0051-0141,FDA,FDA-1998-N-0051,Attachment 2 Tylenol Sinus re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T16:45:50Z,,0,0,090000648056e8eb FDA-1998-N-0051-0127,FDA,FDA-1998-N-0051,"Follow-up Letter from National Reye's Syndrome Foundation, Inc. to FDA",Other,Letter(s),2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T14:56:45Z,,0,0,09000064821810e9 FDA-1998-N-0051-0120,FDA,FDA-1998-N-0051,Correction: Application for Exemption from Perrigo Company,Other,Correction(s),2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T13:56:01Z,,0,0,090000648056e8d2 FDA-1998-N-0051-0149,FDA,FDA-1998-N-0051,Attachment 1 Imodium Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T19:21:31Z,,0,0,090000648056e8f3 FDA-1998-N-0051-0132,FDA,FDA-1998-N-0051,Letter from BD Medical Systems to FDA,Other,Letter(s),2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T15:49:07Z,,0,0,090000648056e8dd FDA-1998-N-0051-0139,FDA,FDA-1998-N-0051,Application for Exemption from McNeil Consumer Healthcare,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T16:41:02Z,,0,0,090000648056e8e9 FDA-1998-N-0051-0135,FDA,FDA-1998-N-0051,Application for Exemption from Thursday Plantation Laboratories Ltd,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T16:04:11Z,,0,0,090000648056e8e2 FDA-1998-N-0051-0121,FDA,FDA-1998-N-0051,Application for Exemption from McNeil Consumer Healthcare,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T14:09:25Z,,0,0,090000648056e8d3 FDA-1998-N-0051-0148,FDA,FDA-1998-N-0051,Application for Exemption from McNeil Consumer Healthcare,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T19:19:54Z,,0,0,090000648056e8f2 FDA-1998-N-0051-0115,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T13:37:38Z,,0,0,090000648056e8cd FDA-1998-N-0051-0125,FDA,FDA-1998-N-0051,Attachment 1 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T14:27:11Z,,0,0,090000648056e8d7 FDA-1998-N-0051-0140,FDA,FDA-1998-N-0051,Attachment 1 Tylenol Sinus re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T16:43:20Z,,0,0,090000648056e8ea FDA-1998-N-0051-0122,FDA,FDA-1998-N-0051,Attachment 1 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T14:12:14Z,,0,0,090000648056e8d4 FDA-1998-N-0051-0143,FDA,FDA-1998-N-0051,Attachment 1 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T18:28:29Z,,0,0,090000648056e8ed FDA-1998-N-0051-0137,FDA,FDA-1998-N-0051,Attachment 1 Motrin Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T16:23:05Z,,0,0,090000648056e8e7 FDA-1998-N-0051-0126,FDA,FDA-1998-N-0051,Attachment 2 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T14:28:31Z,,0,0,090000648056e8d8 FDA-1998-N-0051-0133,FDA,FDA-1998-N-0051,Letter from FDA CDER to L Perrigo Company,Other,Letter(s),2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T15:56:08Z,,0,0,090000648056e8e0 FDA-1998-N-0051-0128,FDA,FDA-1998-N-0051,Application for Deferral from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T15:27:51Z,,0,0,090000648056e8d9 FDA-1998-N-0051-0131,FDA,FDA-1998-N-0051,Amendment to Applications for Exemption from Perrigo Company,Other,Amendment,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T15:46:21Z,,0,0,090000648056e8dc FDA-1998-N-0051-0146,FDA,FDA-1998-N-0051,Attachment 1 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T18:45:15Z,,0,0,090000648056e8f0 FDA-1998-N-0051-0117,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T13:47:38Z,,0,0,090000648056e8cf FDA-1998-N-0051-0114,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T13:35:11Z,,0,0,090000648056e8cc FDA-1998-N-0051-0129,FDA,FDA-1998-N-0051,Application for Deferral from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T15:31:14Z,,0,0,090000648056e8da FDA-1998-N-0051-0138,FDA,FDA-1998-N-0051,Attachment 2 Motrin Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T16:24:46Z,,0,0,090000648056e8e8 FDA-1998-N-0051-0116,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-18T04:00:00Z,2016,8,2016-08-18T04:00:00Z,,2016-08-18T13:47:58Z,,0,0,090000648056e8ce FDA-1998-N-0051-0147,FDA,FDA-1998-N-0051,Attachment 2 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T18:47:07Z,,0,0,090000648056e8f1 FDA-1998-N-0051-0123,FDA,FDA-1998-N-0051,Attachment 2 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare,Supporting & Related Material,Application,2016-08-18T04:00:00Z,2016,8,,,2016-08-18T14:14:27Z,,0,0,090000648056e8d5 FDA-1998-N-0051-0094,FDA,FDA-1998-N-0051,"Attachment D BC Label re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:09:13Z,,0,0,090000648056e8b6 FDA-1998-N-0051-0100,FDA,FDA-1998-N-0051,"Letter from Hyman, Phelps and McNamara ( Block Drug Company, Inc.) to FDA DDM",Other,Letter(s),2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-15T15:17:57Z,,0,0,090000648056e8ba FDA-1998-N-0051-0110,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-18T13:24:23Z,,0,0,090000648056e8c8 FDA-1998-N-0051-0093,FDA,FDA-1998-N-0051,"Attachment C BC Label re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:08:53Z,,0,0,090000648056e8b7 FDA-1998-N-0051-0087,FDA,FDA-1998-N-0051,Answer from FDA CDER to Whitehall-Robins Healthcare,Other,Answer,2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-15T14:13:58Z,,0,0,090000648056e8b2 FDA-1998-N-0051-0092,FDA,FDA-1998-N-0051,"Attachment B BC Label re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:08:32Z,,0,0,090000648056e8b8 FDA-1998-N-0051-0096,FDA,FDA-1998-N-0051,"Attachment F BC Label re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:09:55Z,,0,0,090000648056e8b9 FDA-1998-N-0051-0106,FDA,FDA-1998-N-0051,"Appendix A Label, BACTEC Blood Culture Procedural Tray-Unit Package BACTEC Blood Culture Procedural Tray-SKU, 20 Units re: Application for Exemption from BD Medical Systems",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-15T16:12:04Z,,0,0,0900006482175f45 FDA-1998-N-0051-0097,FDA,FDA-1998-N-0051,"Table of Contents re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:10:07Z,,0,0,0900006482175afd FDA-1998-N-0051-0107,FDA,FDA-1998-N-0051,"Appendix B Labels, Drug Prodcuts in BACTEC Blood Culture Procedural Tray re: Application for Exemption from BD Medical Systems",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-15T16:14:46Z,,0,0,0900006482175f46 FDA-1998-N-0051-0104,FDA,FDA-1998-N-0051,Letter from Thursday Plantation Labs Ltd to FDA,Other,Letter(s),2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-15T15:52:36Z,,0,0,090000648056e8c5 FDA-1998-N-0051-0098,FDA,FDA-1998-N-0051,"Appendix 10 Amended Option 2 -Annotated Labeling re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:10:22Z,,0,0,0900006482175b00 FDA-1998-N-0051-0109,FDA,FDA-1998-N-0051,Appendix D Labeling Supplied with the BACTEC Blood Cultural Procedural Tray re: Application for Exemption from BD Medical Systems,Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-15T16:19:49Z,,0,0,0900006482175f6a FDA-1998-N-0051-0095,FDA,FDA-1998-N-0051,"Attachment E BC Label re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:09:35Z,,0,0,090000648056e8b5 FDA-1998-N-0051-0088,FDA,FDA-1998-N-0051,Application for Exemption from L. Perrigo Company,Other,Application,2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-15T14:17:49Z,,0,0,090000648056e8b0 FDA-1998-N-0051-0111,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-18T13:25:37Z,,0,0,090000648056e8c9 FDA-1998-N-0051-0108,FDA,FDA-1998-N-0051,"Appendix C Labels, Device Products in BACTEC Blood Culture Procedural Tray re: Application for Exemption from BD Medical Systems",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-15T16:17:18Z,,0,0,0900006482175f69 FDA-1998-N-0051-0091,FDA,FDA-1998-N-0051,"Attachment A BC Label re: Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Supporting & Related Material,Background Material,2016-08-15T04:00:00Z,2016,8,,,2016-08-22T14:08:09Z,,0,0,090000648056e8b3 FDA-1998-N-0051-0113,FDA,FDA-1998-N-0051,Application for Exemption from Perrigo Company,Other,Application,2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-18T13:29:17Z,,0,0,090000648056e8cb FDA-1998-N-0051-0090,FDA,FDA-1998-N-0051,"Amendment from Hyman, Phelps and McNamara (Block Drug Company, Inc.)",Other,Amendment,2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-22T14:07:41Z,,0,0,090000648056e8b4 FDA-1998-N-0051-0099,FDA,FDA-1998-N-0051,Memorandum of Telephone Conversation,Other,Memorandum,2016-08-15T04:00:00Z,2016,8,2016-08-15T04:00:00Z,,2016-08-15T15:13:08Z,,0,0,090000648056e8bb