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

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152 rows where docket_id = "FDA-1980-N-0038" and posted_year = 2017 sorted by posted_date descending

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  • 2017 · 152 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0038-0121 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Evaluation of a Topical Steroid Antibiotic Combination (Halcinonide-Neomycin-Amphotericin) in the Treatment of Cutaneous Candidiasis and Inflammatory Dermatoses re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:56:50Z   0 0 09000064805b9631
FDA-1980-N-0038-0138 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certain Topical Anti-Infective Drug Products; Vioform-Hydrocortisone (Iodochlorhydroxyquin and Hydrocortisone) Request of CIBA-GEIGY Corporation for Hearing Vol I re: Supplement from CIBA-GEIGY (Wald, Harkrader & Ross) (Vol 1 of 3) Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:11:59Z   0 0 09000064805b963e
FDA-1980-N-0038-0150 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 3 of 5) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:19:03Z   0 0 0900006482cd5c29
FDA-1980-N-0038-0156 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from Clay-Park Labs, Inc. Other Request for Hearing 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:23:17Z   0 0 09000064805b964a
FDA-1980-N-0038-0141 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Letter from Miles Laboratories, Inc. to FDA/DDM Other Letter(s) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:13:51Z   0 0 09000064805b963f
FDA-1980-N-0038-0122 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Clinical Evaluation of a New Halcinonide-Antifungal Combination re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:57:25Z   0 0 09000064805b9632
FDA-1980-N-0038-0120 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Combined Steroid-Antiinfective Topical Therapy in Common Dermatoses A Double- Blind, Multi-Center Study of Iodochlorhydroxyquin-Hydrocortisone in 277 Patients re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:55:20Z   0 0 09000064805b9630
FDA-1980-N-0038-0153 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Answer Letter from Arthur Hull Hayes, Jr. to American Academy of Dermatology, Inc. Other Answer 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:21:20Z   0 0 09000064805b9647
FDA-1980-N-0038-0155 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Letter from Linda M. Quinones to American Academy of Dermatology, Inc. Other Letter(s) 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:22:12Z   0 0 09000064805b9649
FDA-1980-N-0038-0128 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin-Hydrocortisone Treatment of Fungal Infections re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:00:02Z   0 0 09000064805b9638
FDA-1980-N-0038-0148 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 1 of 5) Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:40Z   0 0 09000064805b9646
FDA-1980-N-0038-0152 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 5 of 5) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:19:25Z   0 0 0900006482cd4ff8
FDA-1980-N-0038-0151 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 4 of 5) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:19:13Z   0 0 0900006482cd5304
FDA-1980-N-0038-0133 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Merck Sharp & Dohme Research Labs (Vol. 1 of 4) Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:05:18Z   0 0 09000064805b963c
FDA-1980-N-0038-0142 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Withdrawal Letter from Miles Laboratories, Inc. Other Withdrawal 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:19:41Z   0 0 09000064805b9640
FDA-1980-N-0038-0147 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Mayrand, Inc. Pharmaceuticals Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:39Z   0 0 09000064805b9645
FDA-1980-N-0038-0145 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from UAD Laboratories, Inc. Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:40Z   0 0 09000064805b9643
FDA-1980-N-0038-0123 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:58:13Z   0 0 09000064805b9633
FDA-1980-N-0038-0124 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Vioform-Hydrocortisone in Varicose Ulcer re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:58:38Z   0 0 09000064805b9634
FDA-1980-N-0038-0119 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from National Pharmaceutical Alliance Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:02:14Z   0 0 09000064805b962f
FDA-1980-N-0038-0131 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorohydroxyquinoline (Vioform) Hydrocortisone Cream and Lotion in Superficial Fungus Infections re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:02:02Z   0 0 09000064805b963b
FDA-1980-N-0038-0143 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Correction from the Lemmon Company Other Correction(s) 2017-12-28T05:00:00Z 2017 12     2018-01-02T20:45:08Z   0 0 09000064805b9641
FDA-1980-N-0038-0140 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certain Topical Anti-Infective Drug Products; Vioform-Hydrocortisone (Iodochlorhydroxyquin and Hydrocortisone) Request of CIBA-GEIGY Corporation for Hearing Vol II re: Supplement from CIBA-GEIGY (Wald, Harkrader & Ross) (Vol. 3 of 3) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:12:50Z   0 0 0900006482ceabb3
FDA-1980-N-0038-0125 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Management of Chronic Eczematoid Dermatitis of the Hands re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:59:02Z   0 0 09000064805b9635
FDA-1980-N-0038-0137 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 The Proposal to Withdraw the New Drug Application for Terra-Cortril Topical Ointment (NDA 61-011, Section 446.567(a)) - Submission of Data for Terra-Cortril Topical Ointment re Supplement from Pfizer Inc. Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:11:19Z   0 0 09000064805b963d
FDA-1980-N-0038-0144 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Marnel Pharmaceuticals, Inc. Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T07:27:06Z   0 0 09000064805b9642
FDA-1980-N-0038-0149 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 2 of 5) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:55Z   0 0 0900006482cd514a
FDA-1980-N-0038-0146 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Dermik Laboratories, Inc. Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:40Z   0 0 09000064805b9644
FDA-1980-N-0038-0154 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Amendment from BYK-Gulden, Inc. (Covington & Burling) Other Amendment 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:21:07Z   0 0 09000064805b9648
FDA-1980-N-0038-0127 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Vioform and Hydrocortisone in Dermatologic Therapy re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:59:44Z   0 0 09000064805b9637
FDA-1980-N-0038-0132 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:02:51Z   0 0 0900006482cead96
FDA-1980-N-0038-0157 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Syntex Laboratories (Kleinfeld, Kaplan and Becker) Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:24:45Z   0 0 09000064805b964b
FDA-1980-N-0038-0134 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Merck Sharp & Dohme Research Labs (Vol. 2 of 4) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:08:42Z   0 0 0900006482ce4983
FDA-1980-N-0038-0135 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Merck Sharp & Dohme Research Labs (Vol. 3 of 4) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:08:57Z   0 0 0900006482ce2f76
FDA-1980-N-0038-0126 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Use of Vioform-Hydrocortisone in Dermatology re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:59:22Z   0 0 09000064805b9636
FDA-1980-N-0038-0129 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Clinical Trial - A Comparison of Two Antiseptic and Steroid Creams re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:00:49Z   0 0 09000064805b9639
FDA-1980-N-0038-0130 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Treatment of Nummular Eczema re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:01:17Z   0 0 09000064805b963a
FDA-1980-N-0038-0136 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Merck Sharp & Dohme Research Labs (Vol. 4 of 4) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:09:07Z   0 0 0900006482ce24be
FDA-1980-N-0038-0139 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certain Topical Anti-Infective Drug Products; Vioform-Hydrocortisone (Iodochlorhydroxyquin and Hydrocortisone) Request of CIBA-GEIGY Corporation for Hearing Vol I re: Supplement from CIBA-GEIGY (Wald, Harkrader & Ross) (Vol 2 of 3) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:12:32Z   0 0 0900006482cea3af
FDA-1980-N-0038-0117 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from E. R. Squibbs & Sons (Vol. 1 of 2) Other Supplement (SUP) 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:18:57Z   0 0 09000064805b962e
FDA-1980-N-0038-0110 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Lilly Research Laboratories (Vol. 2 of 2) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T14:23:53Z   0 0 0900006482ce4fab
FDA-1980-N-0038-0104 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Byk-Gilden, Inc. (Vol. 2 of 2) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T14:12:03Z   0 0 0900006482cdc3a3
FDA-1980-N-0038-0112 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Syntex Laboratories, Inc. (Vol. 3 of 3) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:03:07Z   0 0 0900006482cd6e93
FDA-1980-N-0038-0113 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Syntex Laboratories, Inc. (Vol. 1 of 3) Other Supplement (SUP) 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:19:54Z   0 0 09000064805b962c
FDA-1980-N-0038-0103 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Byk-Gilden, Inc. (Vol. 1 of 2) Other Supplement (SUP) 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:20:26Z   0 0 09000064805b9629
FDA-1980-N-0038-0107 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request of Dermik Laboratories, Inc., for Withdrawal of Notice of Opportunity for Hearing and Submission in Support of Request for Hearing (Vol. 3 of 4) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T14:20:05Z   0 0 0900006482cdcd55
FDA-1980-N-0038-0114 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. ( Vol. 1 of 3) Other Supplement (SUP) 2017-12-27T05:00:00Z 2017 12     2020-01-31T06:55:41Z   0 0 09000064805b962d
FDA-1980-N-0038-0115 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. ( Vol. 2 of 3) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:13:21Z   0 0 0900006482cd795e
FDA-1980-N-0038-0118 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from E. R. Squibbs & Sons (Vol. 2 of 2) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:18:43Z   0 0 0900006482cd81cf
FDA-1980-N-0038-0102 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Letter from the Upjohn Company to FDA/DDM Other Letter(s) 2017-12-27T05:00:00Z 2017 12     2017-12-28T17:51:24Z   0 0 09000064805b9627
FDA-1980-N-0038-0105 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request of Dermik Laboratories, Inc., for Withdrawal of Notice of Opportunity for Hearing and Submission in Support of Request for Hearing (Vol. 1 of 4) Other Supplement (SUP) 2017-12-27T05:00:00Z 2017 12     2017-12-27T14:18:28Z   0 0 09000064805b962a
FDA-1980-N-0038-0106 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request of Dermik Laboratories, Inc., for Withdrawal of Notice of Opportunity for Hearing and Submission in Support of Request for Hearing (Vol. 2 of 4) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T14:18:15Z   0 0 0900006482cdc431
FDA-1980-N-0038-0111 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Syntex Laboratories, Inc. (Vol. 2 of 3) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:02:51Z   0 0 0900006482cd7133
FDA-1980-N-0038-0109 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Lilly Research Laboratories (Vol. 1 of 2) Other Supplement (SUP) 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:20:05Z   0 0 09000064805b962b
FDA-1980-N-0038-0108 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request of Dermik Laboratories, Inc., for Withdrawal of Notice of Opportunity for Hearing and Submission in Support of Request for Hearing (Vol. 4 of 4) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T14:21:50Z   0 0 0900006482cd795d
FDA-1980-N-0038-0116 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. ( Vol. 3 of 3) Supporting & Related Material Background Material 2017-12-27T05:00:00Z 2017 12     2017-12-27T15:13:51Z   0 0 0900006482cd61ce
FDA-1980-N-0038-0101 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Letter from Buchanan Ingersoll & Rooney PC Other Letter(s) 2017-12-26T05:00:00Z 2017 12 2017-12-26T05:00:00Z   2017-12-26T21:04:22Z   0 0 0900006482d73f4b
FDA-1980-N-0038-0099 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Combined Steroid-Antiinfective Topical Therapy in Common Dermatoses: A Double-Blind, Multi-Center Study of Iodochlorhydroxyquin-Hydrocortisone in 277 Patients re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:22:15Z   0 0 09000064805b9625
FDA-1980-N-0038-0093 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Treatment of Nummular Eczema re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:15:53Z   0 0 09000064805b961f
FDA-1980-N-0038-0097 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin-Hydrocortisone Treatment of Fungal Infections re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:20:20Z   0 0 09000064805b9623
FDA-1980-N-0038-0082 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Clinical Evaluation of a New Halcinonide-Antifungal Combination re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:01:11Z   0 0 09000064805b9615
FDA-1980-N-0038-0077 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Management of Chronic Eczematoid Dermatitis of the Hands re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:28:59Z   0 0 09000064805b960e
FDA-1980-N-0038-0096 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Evaluation of a Topical Steroid Antibiotic Combination (Halcinonide-Neomycin-Amphotericin) in the Treatment of Cutaneous Candidiasis and Inflammatory Dermatoses re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:19:08Z   0 0 09000064805b9622
FDA-1980-N-0038-0076 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Use of Vioform-Hydrocortisone in Dermatology re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:28:11Z   0 0 09000064805b960d
FDA-1980-N-0038-0087 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplemental from Mallard Inc. Other Supplement (SUP) 2017-12-22T05:00:00Z 2017 12     2017-12-27T15:23:24Z   0 0 09000064805b9619
FDA-1980-N-0038-0088 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:11:54Z   0 0 09000064805b961a
FDA-1980-N-0038-0084 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Vioform and Hydrocortisone in Dermatologic Therapy re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:02:20Z   0 0 09000064805b9617
FDA-1980-N-0038-0074 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplemental from Ambix Laboratories Other Supplement (SUP) 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:19:43Z   0 0 09000064805b960f
FDA-1980-N-0038-0095 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 A Therapeutic Armamentarium for the Treatment of Skin Diseases in Industrial Medical Practice re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:18:22Z   0 0 09000064805b9621
FDA-1980-N-0038-0086 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin re: Supplement from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:04:12Z   0 0 0900006482ce9ea7
FDA-1980-N-0038-0083 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorohydroxyquinoline (Vioform) Hydrocortisone Cream and Lotion in Superficial Fungus Infections re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:01:53Z   0 0 09000064805b9616
FDA-1980-N-0038-0098 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Clinical Evaluation of a New Halcinonide-Antifungal Combination re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:20:53Z   0 0 09000064805b9624
FDA-1980-N-0038-0079 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin-Hydrocortisone Treatment of Fungal Infections re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:30:35Z   0 0 09000064805b9611
FDA-1980-N-0038-0085 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Combined Steroid-Antiinfective Topical Therapy in Common Dermatoses: A Double-Blind, Multi-Center Study of Iodochlorhydroxyquin-Hydrocortisone in 277 Patients re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:02:55Z   0 0 09000064805b9618
FDA-1980-N-0038-0078 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Evaluation of a Topical Steroid Antibiotic Combination (Halcinonide-Neomycin-Amphotericin) in the Treatment of Cutaneous Candidiasis and Inflammatory Dermatoses re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:29:54Z   0 0 09000064805b9610
FDA-1980-N-0038-0091 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Use of Vioform-Hydrocortisone in Dermatology re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:13:33Z   0 0 09000064805b961d
FDA-1980-N-0038-0092 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Management of Chronic Eczematoid Dermatitis of the Hands re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:15:01Z   0 0 09000064805b961e
FDA-1980-N-0038-0081 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Clinical Trial - A Comparison of Two Antiseptic and Steroid Creams re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:38:23Z   0 0 09000064805b9614
FDA-1980-N-0038-0090 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorohydroxyquinoline (Vioform) Hydrocortisone Cream and Lotion in Superficial Fungus Infections re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:12:54Z   0 0 09000064805b961c
FDA-1980-N-0038-0089 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Vioform-Hydrocortisone in Varicose Ulcer re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:12:18Z   0 0 09000064805b961b
FDA-1980-N-0038-0100 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Clinical Trial - A Comparison of Two Antiseptic and Steroid Creams re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:23:21Z   0 0 09000064805b9626
FDA-1980-N-0038-0080 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Vioform-Hydrocortisone in Varicose Ulcer re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:31:22Z   0 0 09000064805b9612
FDA-1980-N-0038-0075 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Treatment of Nummular Eczema re: Supplemental from Ambix Laboratories Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T13:27:47Z   0 0 09000064805b960c
FDA-1980-N-0038-0094 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Vioform and Hydrocortisone in Dermatologic Therapy re: Supplemental from Mallard Inc. Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T17:17:07Z   0 0 09000064805b9620
FDA-1980-N-0038-0040 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from NMC Laboratories, Inc. Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T15:28:57Z   0 0 09000064805b95da
FDA-1980-N-0038-0034 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from Ciba-Geigy Corporation (Wald, Harkrader & Ross) Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T14:04:04Z   0 0 09000064805b95d0
FDA-1980-N-0038-0051 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from Mayrand, Inc. Pharmaceuticals Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T15:57:53Z   0 0 09000064805b95ef
FDA-1980-N-0038-0050 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from UAD Laboratories, Inc. Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T15:55:45Z   0 0 09000064805b95ed
FDA-1980-N-0038-0071 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Evaluation of A Topical Steroid Antibiotic Combination (Halcinonide-Neomycin-Amphotericin) In The Treatment of Cutaneous Candidiasis & Inflammatory Dermatoses re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2017-12-21T05:00:00Z 2017 12     2017-12-21T19:59:12Z   0 0 09000064805b9600
FDA-1980-N-0038-0055 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Letter from FDA to Robert H. Becker, Esq. Other Letter(s) 2017-12-21T05:00:00Z 2017 12     2017-12-21T16:12:54Z   0 0 09000064805b95f7
FDA-1980-N-0038-0067 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin-Hydrocortisone Treatment of Fungal Infections re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2017-12-21T05:00:00Z 2017 12     2020-01-31T06:55:41Z   0 0 09000064805b9607
FDA-1980-N-0038-0049 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from Saron Pharmacal Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T15:54:24Z   0 0 09000064805b95eb
FDA-1980-N-0038-0064 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Treatment of Nummular Eczema re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2017-12-21T05:00:00Z 2017 12     2017-12-21T19:39:50Z   0 0 09000064805b9604
FDA-1980-N-0038-0063 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Use of Vioform-Hydrocortisone In Dermatology re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2017-12-21T05:00:00Z 2017 12     2017-12-21T19:32:38Z   0 0 09000064805b9603
FDA-1980-N-0038-0066 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Vioform and Hydrocortisone in Dermatologic Therapy re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2017-12-21T05:00:00Z 2017 12     2017-12-21T19:43:36Z   0 0 09000064805b9606
FDA-1980-N-0038-0065 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorohydroxyquinoline (Vioform) Hydrocortisone Cream and Lotion in Superficial Fungus Infections re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2017-12-21T05:00:00Z 2017 12     2017-12-21T19:43:08Z   0 0 09000064805b9605
FDA-1980-N-0038-0056 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from Marnel Pharmaceuticals, Inc. Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T16:15:45Z   0 0 09000064805b95f8
FDA-1980-N-0038-0036 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from NMC Laboratories, Inc. Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T14:16:37Z   0 0 09000064805b95d3
FDA-1980-N-0038-0073 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Vioform-Hydrocortisone in Varicose Ulcer re: Supplement from Hyrex Pharmaceuticals Supporting & Related Material Background Material 2017-12-21T05:00:00Z 2017 12     2017-12-21T20:00:09Z   0 0 0900006482ce9d53
FDA-1980-N-0038-0041 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from National Pharmaceutical Alliance Other Request for Hearing 2017-12-21T05:00:00Z 2017 12     2017-12-21T15:32:40Z   0 0 09000064805b95dc

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