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182 rows where agency_id = "FDA" and docket_id = "FDA-1998-N-0051" sorted by posted_date descending
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posted_year 13
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- Other 121
- Supporting & Related Material 53
- Rule 7
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- FDA · 182 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | Over the Counter Human Drugs Labeling Requirements 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 | 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 |
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