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109 rows where docket_id = "FDA-1998-N-0051" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 109 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0051-0182 FDA Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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 Over the Counter Human Drugs Labeling Requirements 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
FDA-1998-N-0051-0105 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Application for Exemption from BD Medical Systems Other Application 2016-08-15T04:00:00Z 2016 8 2016-08-15T04:00:00Z   2016-08-15T16:00:11Z   0 0 090000648056e8c6
FDA-1998-N-0051-0112 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Application for Exemption from Perrigo Company Other Application 2016-08-15T04:00:00Z 2016 8 2016-08-15T04:00:00Z   2016-08-18T13:27:54Z   0 0 090000648056e8ca
FDA-1998-N-0051-0089 FDA Over the Counter Human Drugs Labeling Requirements 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   2016-08-15T14:20:04Z   0 0 090000648056e8b1
FDA-1998-N-0051-0084 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Application for Exemption from Whitehall Robins Healthcare Other Application 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-11T19:31:15Z   0 0 090000648056e8ab
FDA-1998-N-0051-0083 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Appendix A: 1984 CHPA Voluntary Inactive Ingredient Labeling Program (reprinted 1996) re: Citizen Petition from Consumer Healthcare Products Association (CHPA) Supporting & Related Material Background Material 2016-08-11T04:00:00Z 2016 8     2016-08-11T19:27:33Z   0 0 090000648216f224
FDA-1998-N-0051-0074 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Attachment E: November 29 “Tan Sheet” Press Report of November 23 Meeting re: Memorandum of FDA Working Group Meeting November 23, 1999 from Consumer Healthcare Products Association Supporting & Related Material Background Material 2016-08-11T04:00:00Z 2016 8     2016-08-11T14:39:55Z   0 0 090000648216e1a1
FDA-1998-N-0051-0081 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Answer from FDA CDER to Block Drug Company, Inc. (Hyman, Phelps & McNamara, P.C.) Other Answer 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-11T19:05:05Z   0 0 090000648056e8aa
FDA-1998-N-0051-0080 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Cover Page for Citizen Petition from Arnall, Golden & Gregory LLP Other Citizen Petition 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-17T19:30:45Z   0 0 090000648056e8bc
FDA-1998-N-0051-0072 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Attachment C: CHPA Overhead Slides for November 23 Meeting re: Memorandum of FDA Working Group Meeting November 23, 1999 from Consumer Healthcare Products Association Supporting & Related Material Background Material 2016-08-11T04:00:00Z 2016 8     2016-08-11T14:40:43Z   0 0 090000648216dc8c
FDA-1998-N-0051-0079 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Answer from FDA CDER to Johnson and Johnson Merck Other Answer 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-11T18:38:37Z   0 0 090000648056e8ad
FDA-1998-N-0051-0068 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Answer from FDA CDER to Zee Medical, Inc. Other Answer 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-11T13:57:54Z   0 0 090000648056e880
FDA-1998-N-0051-0070 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Attachment A: FDA Agenda for November 23, 1999 Working Group Meeting re: Memorandum of FDA Working Group Meeting November 23, 1999 from Consumer Healthcare Products Association Supporting & Related Material Background Material 2016-08-11T04:00:00Z 2016 8     2016-08-11T14:23:46Z   0 0 090000648216dc8a
FDA-1998-N-0051-0082 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Citizen Petition from Consumer Healthcare Products Association (CHPA) Other Citizen Petition 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-11T19:23:52Z   0 0 090000648056e8bd
FDA-1998-N-0051-0071 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Attachment B: CTFA October 18, 1999 Letter and Memorandum to FDA re: Memorandum of FDA Working Group Meeting November 23, 1999 from Consumer Healthcare Products Association Supporting & Related Material Background Material 2016-08-11T04:00:00Z 2016 8     2016-08-11T14:27:52Z   0 0 090000648216dc8b
FDA-1998-N-0051-0073 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Attachment D: FDA Overhead Narrative Slides for November 23 Meeting re: Memorandum of FDA Working Group Meeting November 23, 1999 from Consumer Healthcare Products Association Supporting & Related Material Background Material 2016-08-11T04:00:00Z 2016 8     2016-08-11T14:37:52Z   0 0 090000648216e1a0
FDA-1998-N-0051-0069 FDA Over the Counter Human Drugs Labeling Requirements FDA-1998-N-0051 Memorandum of FDA Working Group Meeting November 23, 1999 from Consumer Healthcare Products Association Supporting & Related Material Background Material 2016-08-11T04:00:00Z 2016 8     2016-08-11T18:22:21Z   0 0 090000648056e881

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