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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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640 rows where docket_id = "FDA-1980-N-0038" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1980-N-0038-0652 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Response to the Final Decision on the Proposal to Withdraw Approval of New Drug Applications for Vioform-Hydrocortisone Cream, Ointment, and Lotion Containing Iodochlorhydroxyquin and Hydrocortisone Other Response(s) 2021-09-29T04:00:00Z 2021 9 2021-09-29T04:00:00Z   2021-09-29T19:35:26Z   0 0 0900006484db26fd
FDA-1980-N-0038-0651 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Final Decision from FDA OC to Buchanan Ingersoll & Rooney PC Other Decision 2020-09-30T04:00:00Z 2020 9 2020-10-16T04:00:00Z   2020-10-16T17:10:58Z   0 0 090000648491383f
FDA-1980-N-0038-0650 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Petition for Stay of Action for Hyrex from Buchanan Ingersoll & Rooney PC Other Petition(s) 2020-09-22T04:00:00Z 2020 9 2020-09-22T04:00:00Z   2020-09-22T16:29:21Z   0 0 090000648486f056
FDA-1980-N-0038-0648 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Appeal from Buchanan Ingersoll & Rooney PC Other Appeal 2020-08-14T04:00:00Z 2020 8 2020-08-14T04:00:00Z   2020-08-14T20:59:44Z   0 0 09000064847fe61c
FDA-1980-N-0038-0646 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Vioform-Hydrocortisone Cream, Ointment, and Lotion Containing Iodochlorhydroxyquin and Hydrocortisone; Final Decision on Proposal To Withdraw Approval of New Drug Applications; Opportunity To Affirm Outstanding Appeal Notice Withdrawal 2020-07-15T04:00:00Z 2020 7 2020-07-15T04:00:00Z 2020-08-15T03:59:59Z 2020-08-14T01:01:09Z 2020-15298 0 0 09000064847633da
FDA-1980-N-0038-0628 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.4 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:26Z   0 0 0900006482d144e9
FDA-1980-N-0038-0625 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.14 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:26Z   0 0 0900006482d14a2a
FDA-1980-N-0038-0621 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.7 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:24Z   0 0 0900006482d14b04
FDA-1980-N-0038-0600 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:02:52Z   0 0 0900006482ceae37
FDA-1980-N-0038-0643 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT C-6.1 - Amendment to New Drug Application Locorten 0.02% w/Vioform 3% Cream NDA 16-380 - 12-30-71 Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:32Z   0 0 0900006482cf3977
FDA-1980-N-0038-0618 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.8 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:23Z   0 0 0900006482d14c51
FDA-1980-N-0038-0613 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.9 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:21Z   0 0 0900006482d15dfd
FDA-1980-N-0038-0601 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Reference of Memorandum from FDA Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2020-01-31T06:55:56Z   0 0 0900006482cefd57
FDA-1980-N-0038-0641 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT C-13.1: Submission of Data, Information, Analyses, and Views in Support of the Request for Hearing for Neo-Synalar Cream (NDA 60-700) Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:30Z   0 0 0900006482cfbb34
FDA-1980-N-0038-0639 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT C-1.2 - Appendix to Request for Hearing of CIBA-GEIGY Corp. - 11-24-81 Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:29Z   0 0 0900006482d09560
FDA-1980-N-0038-0614 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.8 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:21Z   0 0 0900006482d15b0b
FDA-1980-N-0038-0617 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.9 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:23Z   0 0 0900006482d14c55
FDA-1980-N-0038-0624 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.6 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:25Z   0 0 0900006482d14e9c
FDA-1980-N-0038-0644 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Comment from Byk-Gulden, Inc. Other Letter(s) 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:19:39Z   0 0 0900006482cf7721
FDA-1980-N-0038-0620 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.2 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:23Z   0 0 0900006482d14b97
FDA-1980-N-0038-0616 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBITS C-13.3, C-13.4, C-13.5, C-13.6, C-13.7, C-15.1, C-15.2 & C-15.3 Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:22Z   0 0 0900006482d1508b
FDA-1980-N-0038-0609 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.11 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:20Z   0 0 0900006482d161d7
FDA-1980-N-0038-0599 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certificate of Service re: Request for Hearing from Premo Pharmaceutical Laboratories, Inc. (Hamel, Park, McCabe & Saunders) Other Certificate of Service 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:01:50Z   0 0 0900006482ce8a55
FDA-1980-N-0038-0594 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Motion from Ciba-Geigy Corporation Other Motion 2018-02-14T05:00:00Z 2018 2     2018-02-14T15:50:10Z   0 0 09000064805b96d6
FDA-1980-N-0038-0631 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.11 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:27Z   0 0 0900006482d14387
FDA-1980-N-0038-0637 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.2 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:29Z   0 0 0900006482d13400
FDA-1980-N-0038-0615 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.5 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:22Z   0 0 0900006482d1581a
FDA-1980-N-0038-0635 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT C-13.2: Submission of Data, Information, Analyses, and Views in Support of the Request for Hearing for Neo-Synalar Cream (NDA 60-700) Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2020-01-31T06:55:57Z   0 0 0900006482d13df0
FDA-1980-N-0038-0619 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.7 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:23Z   0 0 0900006482d14b98
FDA-1980-N-0038-0623 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.15 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:25Z   0 0 0900006482d14ec3
FDA-1980-N-0038-0608 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.14 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:19Z   0 0 0900006482d165cc
FDA-1980-N-0038-0602 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.13 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:15Z   0 0 0900006482d33ffc
FDA-1980-N-0038-0603 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBITS G-81 thru G-85: Supplemental/Written Direct Testimony Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:17Z   0 0 0900006482d33959
FDA-1980-N-0038-0610 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.10 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:20Z   0 0 0900006482d161d6
FDA-1980-N-0038-0612 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.12 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:20Z   0 0 0900006482d15bc7
FDA-1980-N-0038-0611 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.6 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:20Z   0 0 0900006482d15bc8
FDA-1980-N-0038-0595 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Motion from Ciba-Geigy Corporation Other Motion 2018-02-14T05:00:00Z 2018 2     2018-02-14T15:57:24Z   0 0 09000064805b9744
FDA-1980-N-0038-0640 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT C-2 - The American Academy of Dermatology's Comments on the Availability of Topical Anti-Infective Combinations and Steroid Anti-Infective Combinations Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:30Z   0 0 0900006482cfbb35
FDA-1980-N-0038-0645 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Exhibit AAD-1 - Written and Direct Testimony of Peyton E. Weary, M.D. and Exhibit AAD-2 - Testimony of James J. Leyden, M.D. Supporting & Related Material Testimony 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:20:03Z   0 0 0900006482cf8410
FDA-1980-N-0038-0634 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBITS C-16, C-17, C-18: Supplemental and Additional Analyses of Carpenter, Brecker and Vioform-Locorten Studies Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:28Z   0 0 0900006482d134f6
FDA-1980-N-0038-0636 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBITS C-20 thru C-28: Written Evidence of CIBA-GEIGY Corporation Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:29Z   0 0 0900006482d13404
FDA-1980-N-0038-0596 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Motion from Ciba-Geigy Corporation Other Motion 2018-02-14T05:00:00Z 2018 2     2018-02-14T15:58:02Z   0 0 09000064805b9745
FDA-1980-N-0038-0622 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.4 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:25Z   0 0 0900006482d14830
FDA-1980-N-0038-0633 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.10 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2020-01-31T06:55:57Z   0 0 0900006482d14537
FDA-1980-N-0038-0626 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.5 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:26Z   0 0 0900006482d14a26
FDA-1980-N-0038-0606 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.15 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:18Z   0 0 0900006482d165cf
FDA-1980-N-0038-0605 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBITS G-76 thru G-78: Written Direct Testimony Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:18Z   0 0 0900006482d32294
FDA-1980-N-0038-0598 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Motion of the Center for Drugs and Biologics to Strike Exhibit C-29 Other Motion 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:00:17Z   0 0 09000064805b9767
FDA-1980-N-0038-0627 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.3 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:26Z   0 0 0900006482d1482b
FDA-1980-N-0038-0630 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.12 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:27Z   0 0 0900006482d143ed
FDA-1980-N-0038-0632 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.3 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:28Z   0 0 0900006482d142d9
FDA-1980-N-0038-0629 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-2.13 - Patient report forms from Carpenter Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:27Z   0 0 0900006482d1483d
FDA-1980-N-0038-0607 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT G-4.16 - Patient report forms from Brecker Study Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:19Z   0 0 0900006482d314ba
FDA-1980-N-0038-0593 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Order of Ciba-Geigy from FDA Other Order 2018-02-14T05:00:00Z 2018 2     2018-02-14T15:48:29Z   0 0 09000064805b96aa
FDA-1980-N-0038-0597 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Motion from Ciba-Geigy Corporation Other Motion 2018-02-14T05:00:00Z 2018 2 2018-02-14T05:00:00Z   2018-02-14T15:58:55Z   0 0 09000064805b974a
FDA-1980-N-0038-0642 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT C-7 - E.A. Konopka, Et Al., "Antimicrobial Effectiveness of Locacorten-Vioform Cream in Secondary Infections of Common Dermatoses - 1-8-75 EXHIBIT C-8 - Richard C.M. Miller, M.D., "Flumethasone Pivalate-Iodochlorhydroxyquin Cream: A New Corticosteroid Anti-Infective Combination." - 10-1-74 EXHIBIT C-10.3 - Federal Register Notice - 3-23-82 EXHIBIT C-11 - Federal Register Notice - 3-28-84 Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:31Z   0 0 0900006482cf3dcb
FDA-1980-N-0038-0604 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBIT C-14.14: FDA Medical Review and Evaluation of Vioform-Hydrocortisone Cream (undated—initiated by E. Tabor 7/15/85) EXHIBIT C-14.15: DA Statistical review and evaluation of Vioform-Hydrocortisone (dated July 9, 1985) Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:18Z   0 0 0900006482d3271b
FDA-1980-N-0038-0638 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 EXHIBITS C-14.1, C-14.2, C-14.3, C-14.7: FDA medical and statistical reviews of Vioform- Hydrocortisone and of 1982 AAD submission Supporting & Related Material Background Material 2018-02-14T05:00:00Z 2018 2     2018-02-14T16:17:29Z   0 0 0900006482d133b0
FDA-1980-N-0038-0577 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Exceptions from Clay-Park Labs, Inc. Hyrex Pharmaceuticals, Mallard, Inc., Maynard, Inc. MNC Laboratories, Inc., National Pharmaceutical Alliance and UAD Laboratories, Inc. Other Exception/Waiver 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:43:18Z   0 0 09000064805b9786
FDA-1980-N-0038-0575 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Memorandum to the Record from FDA/DDM Other Memorandum 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:42:14Z   0 0 09000064805b9784
FDA-1980-N-0038-0579 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Exceptions of CIBA-GEIGY Corporation to Initial Decision and Brief in Support of Exceptions (Sutherland, Asbill & Brennan) Other Exception/Waiver 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:44:31Z   0 0 09000064805b9788
FDA-1980-N-0038-0584 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Memorandum of Separation of Functions from Thomas Scarlett Other Separation of Functions 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:48:13Z   0 0 09000064805b978f
FDA-1980-N-0038-0583 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certificate of Service from FDA Other Certificate of Service 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:47:47Z   0 0 09000064805b978e
FDA-1980-N-0038-0572 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Order from FDA Other Order 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:13:50Z   0 0 09000064805b9780
FDA-1980-N-0038-0586 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certificate of Service re: Correction from FDA CDER Other Certificate of Service 2018-02-01T05:00:00Z 2018 2     2020-01-31T06:55:56Z   0 0 0900006482ce99fb
FDA-1980-N-0038-0587 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Reply to Ciba-Geigy's Exceptions From FDA/CDER Other Reply 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:58:27Z   0 0 09000064805b9791
FDA-1980-N-0038-0581 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Extension from FDA/CDER Other Request for Extension 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:46:47Z   0 0 09000064805b978b
FDA-1980-N-0038-0578 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Exceptions from Lemmon Company Other Exception/Waiver 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:44:03Z   0 0 09000064805b9787
FDA-1980-N-0038-0585 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Correction from FDA CDER Other Correction(s) 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:48:58Z   0 0 09000064805b9790
FDA-1980-N-0038-0573 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certificate of Service from FDA Other Certificate of Service 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:26:03Z   0 0 09000064805b9781
FDA-1980-N-0038-0591 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Memorandum of Separation of Functions from FDA Other Separation of Functions 2018-02-01T05:00:00Z 2018 2     2018-02-01T15:07:44Z   0 0 09000064805b9797
FDA-1980-N-0038-0589 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Memorandum of Separation of Function from FDA Other Separation of Functions 2018-02-01T05:00:00Z 2018 2     2018-02-01T15:06:05Z   0 0 09000064805b9795
FDA-1980-N-0038-0590 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Memorandum of Separation of Functions from FDA Other Separation of Functions 2018-02-01T05:00:00Z 2018 2     2018-02-01T15:07:14Z   0 0 09000064805b9796
FDA-1980-N-0038-0582 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Order from FDA/CDER Other Order 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:47:25Z   0 0 09000064805b978c
FDA-1980-N-0038-0576 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Exception from Dermik Laboratories Other Exception/Waiver 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:42:50Z   0 0 09000064805b9785
FDA-1980-N-0038-0592 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Memorandum of Separation of Functions from FDA Other Separation of Functions 2018-02-01T05:00:00Z 2018 2     2018-02-01T15:08:05Z   0 0 09000064805b9798
FDA-1980-N-0038-0588 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Reply Brief for Ciba-Geigy Corporation in Support of Exceptions to Initial Decision Other Reply 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:58:52Z   0 0 09000064805b9794
FDA-1980-N-0038-0580 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Correction from Lemmon Company (Kleinfeld, Kaplan and Becker) Other Correction(s) 2018-02-01T05:00:00Z 2018 2     2018-02-01T14:45:35Z   0 0 09000064805b978a
FDA-1980-N-0038-0566 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 List from Ciba-Geigy Corporation, et al Other List (LST) 2018-01-31T05:00:00Z 2018 1     2018-01-31T15:59:37Z   0 0 09000064805b9779
FDA-1980-N-0038-0561 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Briefing Material from Dermik Laboratories, Inc. and The Byk Group Other Brief 2018-01-31T05:00:00Z 2018 1     2018-01-31T14:50:02Z   0 0 09000064805b9774
FDA-1980-N-0038-0570 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Extension from Ciba-Geigy Corporation Other Request for Extension 2018-01-31T05:00:00Z 2018 1     2018-02-02T02:03:00Z   0 0 09000064805b977e
FDA-1980-N-0038-0560 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certificate of Service re: Findings of Fact from Ciba-Geigy Corporation (Sutherland, Asbill & Brennan) Other Certificate of Service 2018-01-31T05:00:00Z 2018 1     2018-01-31T14:32:10Z   0 0 0900006482d09703
FDA-1980-N-0038-0568 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Initial Decision by Admin. Law Judge from FDA Other Initial Decision 2018-01-31T05:00:00Z 2018 1     2018-01-31T16:01:02Z   0 0 0900006482d09f62
FDA-1980-N-0038-0564 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Finding of Facts from Clay-Park Labs, Inc., et al Other Findings of Fact 2018-01-31T05:00:00Z 2018 1     2018-01-31T15:46:56Z   0 0 09000064805b9777
FDA-1980-N-0038-0557 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Motion from Ciba-Geigy Corporation Other Motion 2018-01-31T05:00:00Z 2018 1     2018-01-31T14:30:39Z   0 0 09000064805b979a
FDA-1980-N-0038-0559 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Findings of Fact from Ciba-Geigy Corporation (Sutherland, Asbill & Brennan) Other Findings of Fact 2018-01-31T05:00:00Z 2018 1     2018-01-31T14:31:51Z   0 0 09000064805b9772
FDA-1980-N-0038-0565 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Post-Hearing Brief of the Center for Drugs and Biologics Other Brief 2018-01-31T05:00:00Z 2018 1     2020-01-31T06:55:42Z   0 0 09000064805b9778
FDA-1980-N-0038-0563 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Briefing Material from Clay-Park Labs, Inc. et al Other Brief 2018-01-31T05:00:00Z 2018 1     2018-01-31T15:25:53Z   0 0 09000064805b9776
FDA-1980-N-0038-0562 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Briefing Material from Lemmon Company Other Brief 2018-01-31T05:00:00Z 2018 1     2018-01-31T15:25:20Z   0 0 09000064805b9775
FDA-1980-N-0038-0556 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Stipulation from FDA CDER and Ciba-Geigy Corporation Other Stipulation(s) 2018-01-31T05:00:00Z 2018 1     2018-01-31T14:08:11Z   0 0 09000064805b9770
FDA-1980-N-0038-0558 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Post-Hearing Brief For Ciba-Geigy Corporation (Sutherland, Asbill & Brennan) Other Brief 2018-01-31T05:00:00Z 2018 1     2018-01-31T14:31:12Z   0 0 09000064805b9771
FDA-1980-N-0038-0567 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Reply to Motion from Ciba-Geigy Corporation Other Reply 2018-01-31T05:00:00Z 2018 1     2018-01-31T16:00:26Z   0 0 09000064805b977a
FDA-1980-N-0038-0569 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certificate of Service from FDA Other Certificate of Service 2018-01-31T05:00:00Z 2018 1     2018-01-31T16:02:24Z   0 0 09000064805b977c
FDA-1980-N-0038-0571 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Reply Comment from FDA CDER Other Reply Comments 2018-01-31T05:00:00Z 2018 1     2018-01-31T20:08:44Z   0 0 09000064805b977f
FDA-1980-N-0038-0550 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Order from FDA Other Order 2018-01-30T05:00:00Z 2018 1     2018-01-30T16:42:11Z   0 0 09000064805b976a
FDA-1980-N-0038-0549 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certificate of Service from FDA Other Certificate of Service 2018-01-30T05:00:00Z 2018 1     2018-01-30T16:12:19Z   0 0 09000064805b9769
FDA-1980-N-0038-0548 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Order from FDA Other Order 2018-01-30T05:00:00Z 2018 1     2018-01-30T16:11:33Z   0 0 09000064805b9768
FDA-1980-N-0038-0543 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Motion from Ciba-Geigy Corporation Other Motion 2018-01-30T05:00:00Z 2018 1     2018-02-14T16:11:15Z   0 0 09000064805b9739
FDA-1980-N-0038-0553 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Stipulation to Extend Time for Response to Exhibit C-32 from FDA CDER (Sutherland, Asbill & Brennan) Other Stipulation(s) 2018-01-30T05:00:00Z 2018 1     2018-01-30T16:45:10Z   0 0 09000064805b976d
FDA-1980-N-0038-0552 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Drugs for Human Use; Drug Efficacy Study Implementation; Certain Topical Anti-Infective Drug Products; Withdrawal of Approval of New Drug Applications Notice Withdrawal 2018-01-30T05:00:00Z 2018 1     2018-01-30T16:43:49Z 85-19803 0 0 09000064805b976c

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