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withdrawn,object_id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-2017-V-7020-0002,FDA,FDA-2017-V-7020,Acknowledgment Letter from FDA DDM to W6 Restaurant Group LTD,Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T16:38:57Z,,0,0,0900006482d83ab8
FDA-2017-H-6960-0001,FDA,FDA-2017-H-6960,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T18:59:43Z,,0,0,0900006482d84c25
FDA-1994-P-0028-0047,FDA,FDA-1994-P-0028,"Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo)",Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2017-12-29T16:45:07Z,,0,0,09000064804fd363
FDA-2017-P-7032-0003,FDA,FDA-2017-P-7032,Exhibit 1 Electronic Orange Book re Citizen Petition from Jubilant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:48:54Z,,0,0,0900006482d84ab7
FDA-2017-P-7034-0003,FDA,FDA-2017-P-7034,Exhibit 1 Orange Book Listing re Citizen Petition from Jubilant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:53:20Z,,0,0,0900006482d84d72
FDA-2017-P-7034-0005,FDA,FDA-2017-P-7034,Exhibit 3 Proposed Product Draft Label re Citizen Petition from Jubilant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:53:46Z,,0,0,0900006482d84d74
FDA-2017-P-7032-0005,FDA,FDA-2017-P-7032,Exhibit 3 Draft Labeling for proposed product re Citizen Petition from Jubilant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:49:28Z,,0,0,0900006482d84aba
FDA-2017-H-6973-0001,FDA,FDA-2017-H-6973,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T19:30:07Z,,0,0,0900006482d84ca5
FDA-2017-V-7020-0001,FDA,FDA-2017-V-7020,Variance Application from W6 Restaurant Group LTD,Other,Application for Variance (VAR),2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T16:38:51Z,,0,0,0900006482d83ab6
FDA-2017-P-7031-0002,FDA,FDA-2017-P-7031,"Acknowledgment Letter from FDA DDM to JRRapoza Associates, Inc",Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T17:34:05Z,,0,0,0900006482d8388f
FDA-2017-P-7032-0001,FDA,FDA-2017-P-7032,Citizen Petition from Jubilant Generics Limited,Other,Citizen Petition,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,2018-06-28T03:59:59Z,2018-01-02T16:48:06Z,,0,0,0900006482d843bf
FDA-2017-V-7023-0001,FDA,FDA-2017-V-7023,Variance Application from Platinum AVL,Other,Application for Variance (VAR),2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T16:37:20Z,,0,0,0900006482d83c59
FDA-2017-P-7033-0004,FDA,FDA-2017-P-7033,Exhibit 2 RLD Label re Citizen Petition from Jubliant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:51:33Z,,0,0,0900006482d84da8
FDA-2017-P-7033-0006,FDA,FDA-2017-P-7033,Exhibit 4 Oxetol Dosage & Drug Information re Citizen Petition from Jubliant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:51:56Z,,0,0,0900006482d84daa
FDA-1977-N-0025-0008,FDA,FDA-1977-N-0025,Literature References re: Supplement from Wyeth Consumer Healthcare,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2019-02-04T14:04:52Z,,0,0,09000064805da2fa
FDA-1977-N-0025-0007,FDA,FDA-1977-N-0025,Supplement from Wyeth Consumer Healthcare,Other,Supplement (SUP),2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2019-02-01T15:40:00Z,,0,0,09000064805da2f9
FDA-2017-H-6986-0001,FDA,FDA-2017-H-6986,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T20:05:43Z,,0,0,0900006482d85162
FDA-2017-V-7021-0002,FDA,FDA-2017-V-7021,Acknowledgment Letter from FDA DDM to Trio Nightclub,Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T16:41:48Z,,0,0,0900006482d83abe
FDA-2014-P-0646-0011,FDA,FDA-2014-P-0646,Letter from Kamat Pharmatech to FDA DDM,Other,Letter(s),2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T16:42:48Z,,0,0,0900006482d8388b
FDA-2017-P-7032-0002,FDA,FDA-2017-P-7032,Acknowledgment Letter from FDA DDM to Jubilant Generics Limited,Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2018-01-02T16:48:30Z,,0,0,0900006482d843c1
FDA-2017-H-6948-0001,FDA,FDA-2017-H-6948,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T18:48:22Z,,0,0,0900006482d84e08
FDA-1994-P-0028-0046,FDA,FDA-1994-P-0028,"Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo)",Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2017-12-29T16:44:36Z,,0,0,09000064804fd353
FDA-2017-P-7033-0001,FDA,FDA-2017-P-7033,Citizen Petition from Jubliant Generics Limited,Other,Citizen Petition,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,2018-06-28T03:59:59Z,2018-01-02T16:50:17Z,,0,0,0900006482d84d79
FDA-2017-H-6958-0001,FDA,FDA-2017-H-6958,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T18:54:54Z,,0,0,0900006482d84e3e
FDA-2017-H-6952-0001,FDA,FDA-2017-H-6952,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T18:47:45Z,,0,0,0900006482d84e02
FDA-2017-D-6530-0002,FDA,FDA-2017-D-6530,Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry DRAFT GUIDANCE,Other,Guidance,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,2018-03-30T03:59:59Z,2024-11-07T01:15:37Z,,1,0,0900006482d7eb25
FDA-2017-D-6564-0002,FDA,FDA-2017-D-6564,"Best Practices for Communication Between IND Sponsors and FDA
During Drug Development Guidance for Industry and Review Staff",Other,Guidance,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2024-11-07T01:15:37Z,,1,0,0900006482d7eb23
FDA-2017-P-7031-0003,FDA,FDA-2017-P-7031,"Attachment 1 Orange Book Listing re Citizen Petition from JRRapoza Associates, Inc",Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2017-12-29T17:34:25Z,,0,0,0900006482d83891
FDA-2017-P-7033-0002,FDA,FDA-2017-P-7033,Acknowledgment Letter from FDA DDM to Jubilant Generics Limited,Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2018-01-02T16:50:45Z,,0,0,0900006482d84da4
FDA-2017-P-7034-0001,FDA,FDA-2017-P-7034,Citizen Petition from Jubilant Generics Limited,Other,Citizen Petition,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,2018-06-28T03:59:59Z,2018-01-02T16:52:40Z,,0,0,0900006482d84d2a
FDA-2017-P-7031-0001,FDA,FDA-2017-P-7031,"Citizen Petition from JRRapoza Associates, Inc",Other,Citizen Petition,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,2018-06-28T03:59:59Z,2017-12-29T17:33:49Z,,0,0,0900006482d8388d
FDA-2017-P-7032-0004,FDA,FDA-2017-P-7032,Exhibit 2 RLD Labeling re Citizen Petition from Jubilant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:49:10Z,,0,0,0900006482d84ab8
FDA-2017-P-7034-0006,FDA,FDA-2017-P-7034,Exhibit 4 Valtrex Tablets 250 mg re Citizen Petition from Jubilant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:53:57Z,,0,0,0900006482d84d75
FDA-2017-P-7031-0004,FDA,FDA-2017-P-7031,"Attachment 2 Approved Drug Labeling RLD re Citizen Petition from JRRapoza Associates, Inc",Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2017-12-29T17:34:41Z,,0,0,0900006482d84574
FDA-2017-D-6564-0001,FDA,FDA-2017-D-6564,"Best Practices for Communication Between Investigational New Drug
Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability",Notice,Notice of Availability,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T14:28:34Z,2017-28139,0,0,0900006482d832c0
FDA-2017-D-6530-0001,FDA,FDA-2017-D-6530,Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,2018-03-30T03:59:59Z,2018-03-28T01:02:41Z,2017-28140,0,0,0900006482d832bd
FDA-2016-N-0832-0057,FDA,FDA-2016-N-0832,Letter from Phibro Animal Health Corporation,Other,Letter(s),2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T15:57:53Z,,0,0,0900006482d83a18
FDA-2017-V-7023-0002,FDA,FDA-2017-V-7023,Acknowledgement Letter from FDA DDM to Platinum AVL,Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T16:37:25Z,,0,0,0900006482d83c5c
FDA-2017-P-7033-0003,FDA,FDA-2017-P-7033,Exhibit 1 Orange Book Listing re Citizen Petition from Jubliant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:51:21Z,,0,0,0900006482d84da7
FDA-2017-P-7033-0005,FDA,FDA-2017-P-7033,Exhibit 3 Proposed Product Draft Label re Citizen Petition from Jubliant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:51:45Z,,0,0,0900006482d84da9
FDA-2017-V-7028-0002,FDA,FDA-2017-V-7028,Acknowledgement Letter from FDA DDM to Richard Nguyen,Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T18:19:48Z,,0,0,0900006482d84abf
FDA-2017-H-6963-0001,FDA,FDA-2017-H-6963,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T19:24:17Z,,0,0,0900006482d84efa
FDA-2017-P-7034-0004,FDA,FDA-2017-P-7034,Exhibit 2 RLD Label re Citizen Petition from Jubilant Generics Limited,Supporting & Related Material,Background Material,2017-12-29T05:00:00Z,2017,12,,,2018-01-02T16:53:34Z,,0,0,0900006482d84d73
FDA-2017-P-7034-0002,FDA,FDA-2017-P-7034,Acknowledgment Letter from FDA DDM to Jubilant Generics Limited,Other,Acknowledgement Letter/Receipt,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2018-01-02T16:53:05Z,,0,0,0900006482d84d2c
FDA-2017-H-6953-0001,FDA,FDA-2017-H-6953,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T18:45:41Z,,0,0,0900006482d84e38
FDA-2017-V-7021-0001,FDA,FDA-2017-V-7021,Variance Application from Trio Nightclub,Other,Application for Variance (VAR),2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T16:41:43Z,,0,0,0900006482d83abc
FDA-2017-V-7028-0001,FDA,FDA-2017-V-7028,Variance Application from RICHARD NGUYEN,Other,Application for Variance (VAR),2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T18:19:42Z,,0,0,0900006482d837cd
FDA-2017-H-6972-0001,FDA,FDA-2017-H-6972,Complaint,Other,Complaint,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T19:11:59Z,,0,0,0900006482d84ef4
FDA-1977-N-0025-0009,FDA,FDA-1977-N-0025,Mail Slip re: Supplement from Wyeth Consumer Healthcare,Supporting & Related Material,Transmittals,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2019-02-04T14:03:07Z,,0,0,09000064805da2fb
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-2017-P-4039-0003,FDA,FDA-2017-P-4039,Interim Response Letter from FDA CDER to Center for Lawful Access and Abuse Deterrence,Other,Letter(s),2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T21:28:04Z,,0,0,0900006482d7f298
FDA-2005-D-0140-0012,FDA,FDA-2005-D-0140,"Reference 1 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products,”",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:42Z,,0,0,0900006482d7ee3f
FDA-2005-D-0140-0015,FDA,FDA-2005-D-0140,"Reference 4 Busch MP. Closing the windows on viral transmission by blood transfusion. In Stramer SL ed. Blood Safety in the New Millenium. Bethesda, MD: American Association of Blood Banks, 2001: Chapter 2, p.36.",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:28Z,,0,0,0900006482d7ee42
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-2015-V-0429-0003,FDA,FDA-2015-V-0429,"Approval Letter from FDA CDRH to Power Technology, Inc.",Other,Approval for Variance (VRA),2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T15:21:49Z,,0,0,0900006482d7b398
FDA-2017-H-6956-0001,FDA,FDA-2017-H-6956,Complaint,Other,Complaint,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T15:55:12Z,,0,0,0900006482d7b912
FDA-2017-H-6957-0001,FDA,FDA-2017-H-6957,Complaint,Other,Complaint,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T18:31:50Z,,0,0,0900006482d7c0f5
FDA-2017-H-6954-0001,FDA,FDA-2017-H-6954,Complaint,Other,Complaint,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T15:25:41Z,,0,0,0900006482d7b39a
FDA-2017-H-6962-0001,FDA,FDA-2017-H-6962,Complaint,Other,Complaint,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T19:21:49Z,,0,0,0900006482d7db54
FDA-2001-N-0437-0003,FDA,FDA-2001-N-0437,Supporting Statement - The Current Good Manufacturing Practice for Medicated Feeds,Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2024-11-25T16:34:48Z,,0,0,09000064804e8893
FDA-2005-D-0140-0010,FDA,FDA-2005-D-0140,"Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry:  Guidance for Industry",Other,Guidance,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2024-11-07T01:15:24Z,,1,0,0900006482d7ee3c
FDA-2005-D-0140-0016,FDA,FDA-2005-D-0140,"Reference 5 Glynn SA, Kleinman SH, Wright DJ, Busch MP. International application of the incidence rate/window period model. Transfusion 42:966-972 (2002).",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:23Z,,0,0,0900006482d7ee43
FDA-2017-H-6965-0001,FDA,FDA-2017-H-6965,Complaint,Other,Complaint,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T19:25:13Z,,0,0,0900006482d7e13f
FDA-2005-D-0140-0022,FDA,FDA-2005-D-0140,Reference 11 Alter HJ. To C or not to C: These are the questions. Blood 85:1681-1695 (1995).,Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:39:54Z,,0,0,0900006482d7ee52
FDA-2005-D-0140-0011,FDA,FDA-2005-D-0140,"001 - List of References - Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry Guidance for Industry",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:50Z,,0,0,0900006482d7ee3e
FDA-2005-D-0140-0021,FDA,FDA-2005-D-0140,"Reference 10 Blood Products Advisory Committee, 69th Meeting, June 14, 2001",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:39:59Z,,0,0,0900006482d7ee51
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-2005-D-0140-0019,FDA,FDA-2005-D-0140,"Reference 8 Federal Register, December 14, 1999 (64 FR 71147), Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2, December 1999.",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:08Z,,0,0,0900006482d7ee4f
FDA-2005-D-0140-0020,FDA,FDA-2005-D-0140,"Reference 9 Federal Register, August 24, 2007 (72 FR 48765), Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”); Final Rule.",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:03Z,,0,0,0900006482d7ee50
FDA-2001-N-0437-0004,FDA,FDA-2001-N-0437,Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Medicated Feeds,Notice,Notice of Approval,2017-12-28T05:00:00Z,2017,12,,,2024-11-25T16:30:52Z,01–25763,0,0,09000064804e8894
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-2017-N-6778-0001,FDA,FDA-2017-N-6778,"Fostering Medical Innovation: Case for Quality Voluntary Medical Device
Manufacturing and Product Quality Pilot Program",Notice,Announcement,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T14:57:25Z,2017-28044,0,0,0900006482d7a81e
FDA-2005-D-0140-0018,FDA,FDA-2005-D-0140,"Reference 7 Fiebig EW, Wright DJ, Rawal BD, et. al. Dynamics of HIV-1 viremia and antibody seroconversion in plasma donors: Implications for diagnosis and staging of primary HIV-1 infection. AIDS 17:1871-1879 (2003).",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:13Z,,0,0,0900006482d7ee4e
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-2017-H-6964-0001,FDA,FDA-2017-H-6964,Complaint,Other,Complaint,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T19:23:34Z,,0,0,0900006482d7db87
FDA-2017-V-6985-0001,FDA,FDA-2017-V-6985,Variance Application from Aka Booking Agency,Other,Application for Variance (VAR),2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T15:15:52Z,,0,0,0900006482d73063
FDA-2001-N-0437-0002,FDA,FDA-2001-N-0437,Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds,Notice,30 Day Proposed Information Collection,2017-12-28T05:00:00Z,2017,12,2001-06-15T04:00:00Z,2001-07-17T03:59:59Z,2024-11-25T16:25:48Z,01-15081,0,0,09000064804e8892
FDA-2017-H-6966-0001,FDA,FDA-2017-H-6966,Complaint,Other,Complaint,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T19:32:32Z,,0,0,0900006482d7e147
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-2005-D-0140-0014,FDA,FDA-2005-D-0140,"Reference 3 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),” August 5, 1993.",Supporting & Related Material,Background Material,2017-12-28T05:00:00Z,2017,12,,,2017-12-28T20:40:33Z,,0,0,0900006482d7ee41
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