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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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