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withdrawn,object_id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