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withdrawn,object_id FDA-2007-P-0188-0001,FDA,FDA-2007-P-0188,"Acknowledgement Letter from FDA DDM to Beckloff Associates, Inc.",Other,Acknowledgement Letter/Receipt,2007-12-28T05:00:00Z,2007,12,,,2015-05-07T18:08:20Z,,0,0,090000648042a763 FDA-2007-D-0257-0002,FDA,FDA-2007-D-0257,See Document ID FDA-2007-D-0257-0004,Other,,2007-12-28T00:00:00Z,2007,12,,,2008-05-21T20:21:19Z,,0,1,090000648042b1c4 FDA-2007-P-0414-0005,FDA,FDA-2007-P-0414,Minutes of Telecon Between FDA/CDER and Dr. Victor Yu and Cristina Chiou,Other,MT-Memorandum of Telephone Conversation,2007-12-27T05:00:00Z,2007,12,,,2008-04-04T00:38:15Z,,0,0,090000648042da1a FDA-2007-N-0445-0003,FDA,FDA-2007-N-0445,Number not used,Other,,2007-12-26T05:00:00Z,2007,12,,,2025-08-14T22:07:10Z,,0,1,090000648042ddf6 FDA-2007-N-0197-0002,FDA,FDA-2007-N-0197,Agenda - Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop,Other,LST-List,2007-12-26T05:00:00Z,2007,12,,,2025-08-14T20:30:52Z,,0,0,090000648042a934 FDA-2007-N-0445-0002,FDA,FDA-2007-N-0445,Number Not Used,Other,,2007-12-26T05:00:00Z,2007,12,,,2025-08-14T22:05:39Z,,0,1,090000648042ddf5 FDA-2007-N-0445-0004,FDA,FDA-2007-N-0445,Number not used,Other,,2007-12-26T05:00:00Z,2007,12,,,2025-08-14T22:08:41Z,,0,1,090000648042ddf7 FDA-2007-N-0438-0002,FDA,FDA-2007-N-0438,Acknowledgment Letter from FDA DDM to Buchanan Ingersoll & Rooney PC,Other,Acknowledgement Letter/Receipt,2007-12-26T05:00:00Z,2007,12,,,2025-08-11T20:21:37Z,,0,0,090000648042dd74 FDA-2006-V-0402-0005,FDA,FDA-2006-V-0402,Lynne L. Rice,Other,VRA-Approval for Variance,2007-12-21T05:00:00Z,2007,12,,,2008-04-11T23:22:39Z,,0,0,0900006480460c6c FDA-2007-P-0235-0001,FDA,FDA-2007-P-0235,"Acknowledgment Letter from FDA CDER to Mutual Pharmaceutical Company, Inc.",Other,Acknowledgement Letter/Receipt,2007-12-21T05:00:00Z,2007,12,,,2015-09-29T13:12:16Z,,0,0,090000648042b04d FDA-2007-V-0252-0001,FDA,FDA-2007-V-0252,Acknowledgement Letter to KRJ Music Work,Other,ACK-Acknowledgement Letter,2007-12-21T05:00:00Z,2007,12,,,2008-04-09T14:15:14Z,,0,0,090000648042b160 FDA-2007-V-0356-0003,FDA,FDA-2007-V-0356,Lynne L. Rice - Approval for Variance,Other,VRA-Approval for Variance,2007-12-20T05:00:00Z,2007,12,,,2008-04-09T16:14:25Z,,0,0,090000648042ba0b FDA-2007-A-0099-0002,FDA,FDA-2007-A-0099,Letter from FDA CDER Interim Response to AstraZeneca Ropes and Gray LLP,Other,Letter(s),2007-12-20T05:00:00Z,2007,12,,,2014-01-21T00:25:14Z,,0,0,0900006480429d7a FDA-2007-V-0426-0002,FDA,FDA-2007-V-0426,Lynne L. Rice - Approval for Variance,Other,VRA-Approval for Variance,2007-12-20T05:00:00Z,2007,12,,,2008-04-09T18:31:27Z,,0,0,090000648042dbe4 FDA-2007-P-0243-0001,FDA,FDA-2007-P-0243,Acknowledgement Letter to Michael J. Dochniak,Other,ACK-Acknowledgement Letter,2007-12-20T05:00:00Z,2007,12,,,2008-07-22T22:56:16Z,,0,0,090000648042b0be FDA-2007-P-0184-0001,FDA,FDA-2007-P-0184,Acknowledgement Letter to Judy Slome Cohain,Other,ACK-Acknowledgement Letter,2007-12-18T05:00:00Z,2007,12,,,2008-07-07T17:57:57Z,,0,0,090000648042a728 FDA-2007-P-0110-0001,FDA,FDA-2007-P-0110,FDA/DDM to Physicians Committee for Responsible Medicine (PCRM),Other,ACK-Acknowledgement Letter,2007-12-18T05:00:00Z,2007,12,,,2008-04-04T00:37:11Z,,0,0,0900006480429e5f FDA-2006-P-0275-0006,FDA,FDA-2006-P-0275,Citizen Petition Denial from FDA CDER to KV Pharmaceutical Co,Other,Denial of Petition,2007-12-17T05:00:00Z,2007,12,,,2024-12-05T14:53:49Z,,0,0,090000648045829b FDA-2007-P-0417-0001,FDA,FDA-2007-P-0417,Acknowledgement Letter to Consumers Union,Other,ACK-Acknowledgement Letter,2007-12-17T05:00:00Z,2007,12,,,2013-05-15T19:58:29Z,,0,0,090000648042da4d FDA-2007-P-0122-0052,FDA,FDA-2007-P-0122,FDA/CFSAN Interim Response to Compassion Over Killing & Penn Law Animal Law Project-University of Pennsylvania Law School - Letter,Other,LET-Letter,2007-12-17T05:00:00Z,2007,12,,,2008-11-26T05:47:43Z,,0,0,090000648042a1cf FDA-2005-P-0253-0019,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e7 FDA-2005-P-0253-0006,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442da FDA-2005-P-0253-0005,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442d9 FDA-2005-P-0253-0013,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e1 FDA-2005-P-0253-0012,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e0 FDA-2005-P-0253-0021,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e9 FDA-2005-P-0253-0008,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442dc FDA-2005-P-0253-0016,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e4 FDA-2005-P-0253-0009,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:03Z,,0,0,09000064804442dd FDA-2005-P-0253-0010,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442de FDA-2005-P-0253-0017,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e5 FDA-2005-P-0253-0014,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e2 FDA-2005-P-0253-0015,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e3 FDA-2005-P-0253-0018,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e6 FDA-2005-P-0253-0020,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442e8 FDA-2005-P-0253-0011,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:03Z,,0,0,09000064804442df FDA-2005-P-0253-0007,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442db FDA-2005-P-0253-0022,FDA,FDA-2005-P-0253,"J. Shuren, Assistant Commissioner for Policy",Other,PDN-Petition Denial,2007-12-13T05:00:00Z,2007,12,,,2008-04-12T00:09:02Z,,0,0,09000064804442ea FDA-2007-V-0421-0001,FDA,FDA-2007-V-0421,Acknowledgement Letter to X- Laser L. L. C.,Other,ACK-Acknowledgement Letter,2007-12-12T05:00:00Z,2007,12,,,2008-04-09T18:12:29Z,,0,0,090000648042daca FDA-2007-V-0253-0001,FDA,FDA-2007-V-0253,"Acknowledgement Letter to X- Laser, L. L. C.",Other,ACK-Acknowledgement Letter,2007-12-12T05:00:00Z,2007,12,,,2008-04-09T14:30:16Z,,0,0,090000648042b16e FDA-2007-P-0288-0002,FDA,FDA-2007-P-0288,FDA/CDRH to Clinical and Laboratory Standards Institute,Other,LET-Letter,2007-12-11T05:00:00Z,2007,12,,,2008-04-04T00:37:52Z,,0,0,090000648042b4f1 FDA-2007-P-0187-0001,FDA,FDA-2007-P-0187,FDA/DDM to Alston & Bird LLP,Other,ACK-Acknowledgement Letter,2007-12-11T05:00:00Z,2007,12,,,2008-04-04T00:37:35Z,,0,0,090000648042a754 FDA-2007-P-0115-0002,FDA,FDA-2007-P-0115,CDRH to Clinical and Laboratory Standards Institute,Other,LET-Letter,2007-12-11T05:00:00Z,2007,12,,,2008-04-04T00:37:13Z,,0,0,0900006480429ef7 FDA-2007-P-0187-0002,FDA,FDA-2007-P-0187,FDA/DDM to Alston & Bird LLP,Other,ACK-Acknowledgement Letter,2007-12-11T05:00:00Z,2007,12,,,2008-04-04T00:37:35Z,,0,0,090000648042a759 FDA-2007-P-0066-0001,FDA,FDA-2007-P-0066,FDA/ DDM to William L. Driscoll,Other,ACK-Acknowledgement Letter,2007-12-07T05:00:00Z,2007,12,,,2008-04-04T00:37:08Z,,0,0,09000064804297f2 FDA-2007-E-0281-0005,FDA,FDA-2007-E-0281,FDA/CDER to the USPTO - Letter,Other,LET-Letter,2007-12-06T05:00:00Z,2007,12,,,2026-01-06T23:23:28Z,,0,0,090000648042b44b FDA-2007-P-0245-0003,FDA,FDA-2007-P-0245,FDA/CDER Interim Response to Perdue Pharma L.P. - Letter,Other,LET-Letter,2007-12-06T05:00:00Z,2007,12,,,2009-03-28T18:18:01Z,,0,0,090000648042b0f0 FDA-2007-E-0106-0007,FDA,FDA-2007-E-0106,USPTO to Intervet Inc. - Letter,Other,LET-Letter,2007-12-05T05:00:00Z,2007,12,,,2008-05-02T15:45:09Z,,0,0,0900006480429e1e FDA-2007-P-0234-0001,FDA,FDA-2007-P-0234,"Acknowledgement Letter to Terence J. Mix, Esq.",Other,ACK-Acknowledgement Letter,2007-12-04T05:00:00Z,2007,12,,,2012-09-22T20:26:02Z,,0,0,090000648042b03f FDA-2007-P-0182-0002,FDA,FDA-2007-P-0182,FDA Center for Drug and Evaluation Research Response to Sanofi Aventis - Letter,Other,LET-Letter,2007-12-04T05:00:00Z,2007,12,,,2008-07-15T23:43:46Z,,0,0,090000648042a706 FDA-2007-H-0094-0003,FDA,FDA-2007-H-0094,FDA Division of Dockets Management - Certificate of Service [FDA-2007-H-0094-0018],Other,CS-Certificate of Service,2007-12-03T05:00:00Z,2007,12,,,2026-01-06T23:41:59Z,,0,0,0900006480429d34 FDA-2007-H-0094-0002,FDA,FDA-2007-H-0094,FDA/Administrative Law Judge - Order [FDA-2007-H-0094-0017],Other,OR-Order,2007-12-03T05:00:00Z,2007,12,,,2026-01-06T23:40:08Z,,0,0,0900006480429d33 FDA-2020-D-1925-0001,FDA,FDA-2020-D-1925,Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations),Other,Guidance,2007-12-01T05:00:00Z,2007,12,2020-09-17T04:00:00Z,,2024-11-12T23:24:55Z,,1,0,090000648486323c FDA-2006-P-0006-0005,FDA,FDA-2006-P-0006,Letter from FDA CDER to AAC Consulting Group/Kendle,Other,Letter(s),2007-11-30T05:00:00Z,2007,11,,,2024-11-14T14:39:25Z,,0,0,0900006480441445 FDA-2007-P-0123-0001,FDA,FDA-2007-P-0123,"Acknowledgement Letter to United Research Laboratories, Inc., Mutual Pharmaceutical Company, Inc.",Other,ACK-Acknowledgement Letter,2007-11-30T05:00:00Z,2007,11,,,2008-10-01T15:30:49Z,,0,0,090000648042a1d7 FDA-2005-D-0445-0008,FDA,FDA-2005-D-0445,"Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Final Guidance Document",Other,Guidance,2007-11-30T05:00:00Z,2007,11,,,2015-01-21T00:13:53Z,,0,0,09000064804505f2 FDA-2006-P-0069-0005,FDA,FDA-2006-P-0069,"Letter from FDA CDER to Frommer, Lawrence & Haug LLP",Other,Letter(s),2007-11-30T05:00:00Z,2007,11,,,2024-11-13T14:54:20Z,,0,0,0900006480444465 FDA-2007-P-0247-0006,FDA,FDA-2007-P-0247,"Letter from FDA CDER to Regulus Pharmaceutical Consulting, Inc",Other,Letter(s),2007-11-30T05:00:00Z,2007,11,,,2025-03-04T22:09:52Z,,0,0,090000648042b114 FDA-2006-P-0201-0005,FDA,FDA-2006-P-0201,Elizabeth Sadove - FDA/CDER Final Response,Other,LET-Letter,2007-11-30T05:00:00Z,2007,11,,,2008-06-19T19:56:35Z,,0,0,0900006480450f53 FDA-2006-P-0085-0005,FDA,FDA-2006-P-0085,"Letter from FDA CDER to Sicor Pharmaceuticals, Inc.",Other,Letter(s),2007-11-30T05:00:00Z,2007,11,,,2024-11-04T19:39:47Z,,0,0,090000648044498d FDA-2007-P-0410-0001,FDA,FDA-2007-P-0410,"FDA/DDM to Medicure Pharma, Inc. - Acknowledgement Letter",Other,ACK-Acknowledgement Letter,2007-11-30T05:00:00Z,2007,11,,,2009-03-31T13:27:52Z,,0,0,090000648042d9a6 FDA-2005-D-0227-0019,FDA,FDA-2005-D-0227,FDA/CFSAN Response to Olga Nichols - Answer,Other,Answer,2007-11-29T05:00:00Z,2007,11,,,2012-03-14T01:00:38Z,,0,0,09000064804420a7 FDA-2007-P-0403-0003,FDA,FDA-2007-P-0403,Petition Approval from FDA CVM to Norbrook Inc,Other,Letter(s),2007-11-28T00:00:00Z,2007,11,,,2025-05-09T00:32:49Z,,0,0,090000648042d905 FDA-2005-D-0227-0018,FDA,FDA-2005-D-0227,FDA/CFSAN Response to Taro Dream Inc. (Pamela Day) - Answer,Other,Answer,2007-11-27T05:00:00Z,2007,11,,,2012-03-14T00:52:52Z,,0,0,09000064804420a4 FDA-2007-P-0005-0003,FDA,FDA-2007-P-0005,Interim Response Letter from FDA CDRH to Association of Medical Device Reprocessors,Other,Letter(s),2007-11-27T00:00:00Z,2007,11,,,2025-05-08T19:39:46Z,,0,0,0900006480429280 FDA-2007-P-0109-0001,FDA,FDA-2007-P-0109,Acknowledgement Letter to Mandatory Alternatives Petition Coalition,Other,ACK-Acknowledgement Letter,2007-11-26T05:00:00Z,2007,11,,,2008-05-09T21:44:06Z,,0,0,0900006480429e51 FDA-2007-D-0132-0002,FDA,FDA-2007-D-0132,Guidance,Other,GDL-Guidance,2007-11-23T05:00:00Z,2007,11,,,2019-08-20T18:59:46Z,,0,0,090000648042a2b9 FDA-2006-P-0205-0004,FDA,FDA-2006-P-0205,FDA/CFSAN Request to Dockets Management - Letter,Other,LET-Letter,2007-11-23T05:00:00Z,2007,11,,,2009-01-23T21:32:10Z,,0,0,090000648045139b FDA-1999-D-0048-0007,FDA,FDA-1999-D-0048,Guidance for Industry Impurities in New Veterinary Medicinal Products (Revised) VICH GL11 (R) Revised Final Guidance,Other,Guidance,2007-11-23T05:00:00Z,2007,11,,,2025-06-10T18:44:15Z,,0,0,09000064804a600a FDA-2007-E-0461-0002,FDA,FDA-2007-E-0461,FDA/CDER to U.S. Patent and Trademark Office,Other,LET-Letter,2007-11-21T05:00:00Z,2007,11,,,2008-04-04T00:35:05Z,,0,0,090000648042df85 FDA-2007-E-0282-0002,FDA,FDA-2007-E-0282,FDA/CDER to USPTO - Letter,Other,LET-Letter,2007-11-21T05:00:00Z,2007,11,,,2008-12-05T18:44:49Z,,0,0,090000648042b460 FDA-2006-D-0299-0005,FDA,FDA-2006-D-0299,CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances,Other,Guidance,2007-11-21T05:00:00Z,2007,11,2007-11-21T05:00:00Z,,2024-11-07T21:52:21Z,,1,0,0900006480458fb9 FDA-2007-E-0165-0002,FDA,FDA-2007-E-0165,Letter from FDA/CDER to USPTO,Other,LET-Letter,2007-11-21T05:00:00Z,2007,11,,,2026-01-06T01:03:51Z,,0,0,090000648042a511 FDA-2005-D-0227-0017,FDA,FDA-2005-D-0227,FDA/CFSAN Response to Su Alai - Answer,Other,Answer,2007-11-20T05:00:00Z,2007,11,,,2012-03-14T00:44:08Z,,0,0,09000064804420a2 FDA-2004-P-0338-0005,FDA,FDA-2004-P-0338,Ted Sherwood,Other,MM-Memorandum of Meeting,2007-11-20T05:00:00Z,2007,11,,,2008-04-12T00:49:25Z,,0,0,0900006480473328 FDA-2007-N-0198-0004,FDA,FDA-2007-N-0198,FDA/CFSAN/ONLDS,Other,M-Memorandum,2007-11-20T05:00:00Z,2007,11,,,2008-04-04T00:35:55Z,,0,0,090000648042a9d3 FDA-2007-N-0198-0005,FDA,FDA-2007-N-0198,FDA/CFSAN/ONLDS,Other,TR-Transcript,2007-11-20T05:00:00Z,2007,11,,,2008-04-04T00:35:55Z,,0,0,090000648042a9d4 FDA-2007-N-0198-0003,FDA,FDA-2007-N-0198,FDA/CFSAN/ONLDS,Other,M-Memorandum,2007-11-20T05:00:00Z,2007,11,,,2008-04-04T00:35:55Z,,0,0,090000648042a9d2 FDA-2007-P-0416-0001,FDA,FDA-2007-P-0416,Acknowledgement Letter from FDA DDM to Sapna Lohiya (Royal Medical Group),Other,Acknowledgement Letter/Receipt,2007-11-20T05:00:00Z,2007,11,,,2016-03-10T16:24:35Z,,0,0,090000648042da3a FDA-2007-N-0198-0006,FDA,FDA-2007-N-0198,FDA/CFSAN/ONLDS,Other,TR-Transcript,2007-11-20T05:00:00Z,2007,11,,,2008-04-04T00:35:55Z,,0,0,090000648042a9d5 FDA-2007-P-0064-0002,FDA,FDA-2007-P-0064,FDA/CDER to Center for Dermatology and Laser Surgery,Other,LET-Letter,2007-11-20T05:00:00Z,2007,11,,,2008-04-04T00:37:07Z,,0,0,09000064804297ca FDA-2007-P-0051-0001,FDA,FDA-2007-P-0051,Acknowledgement Letter to Sidelines National Support Network,Other,ACK-Acknowledgement Letter,2007-11-19T05:00:00Z,2007,11,,,2008-04-11T19:55:24Z,,0,0,09000064804296d6 FDA-2006-E-0383-0007,FDA,FDA-2006-E-0383,"Notice of Final Determination from U.S. Patent and Trademark Office to Novo Nordisk, A/S",Other,Letter(s),2007-11-19T05:00:00Z,2007,11,,,2025-12-19T21:52:23Z,,0,0,09000064804603ab FDA-2007-P-0352-0002,FDA,FDA-2007-P-0352,"FDA/CDER Interim Response to Sheppard, Mullin, Richter & Hampton, LLP - Letter",Other,LET-Letter,2007-11-19T05:00:00Z,2007,11,,,2013-07-27T20:40:29Z,,0,0,090000648042b9da FDA-2006-E-0261-0006,FDA,FDA-2006-E-0261,USPTO to Bristol-Myers Squibb Company - Notice of Final Determination,Other,LET-Letter,2007-11-19T05:00:00Z,2007,11,,,2008-05-28T16:43:42Z,,0,0,0900006480457a3a FDA-2007-P-0246-0002,FDA,FDA-2007-P-0246,"FDA/CDER tp Sandoz, Inc.",Other,LET-Letter,2007-11-19T05:00:00Z,2007,11,,,2008-04-04T00:37:46Z,,0,0,090000648042b100 FDA-2007-P-0301-0003,FDA,FDA-2007-P-0301,Letter from FDA CFSAN to Barbara O. Schneeman,Other,Letter(s),2007-11-16T05:00:00Z,2007,11,,,2025-03-13T16:02:17Z,,0,0,090000648042b62b FDA-2007-N-0035-0002,FDA,FDA-2007-N-0035,Number not used,Other,ACK-Acknowledgement Letter,2007-11-15T05:00:00Z,2007,11,,,2008-04-04T00:35:32Z,,0,0,09000064804295b6 FDA-2007-V-0021-0001,FDA,FDA-2007-V-0021,Acknowledgement Letter to Mountain Megabytes Inc.,Other,ACK-Acknowledgement Letter,2007-11-15T05:00:00Z,2007,11,,,2008-04-10T10:55:28Z,,0,0,0900006480429425 FDA-2000-N-0190-0017,FDA,FDA-2000-N-0190,Renee J. Wheeler,Other,MM-Memorandum of Meeting,2007-11-15T05:00:00Z,2007,11,,,2008-04-25T01:18:09Z,,0,0,09000064804d4090 FDA-2005-D-0227-0016,FDA,FDA-2005-D-0227,FDA/CFSAN Response to Patricia Faison (Kellen Company) - Answer,Other,Answer,2007-11-14T05:00:00Z,2007,11,,,2012-03-14T00:35:26Z,,0,0,09000064804420a0 FDA-2005-D-0227-0015,FDA,FDA-2005-D-0227,FDA/CFSAN Response to Jesper Korning (AAK) - Answer,Other,Answer,2007-11-14T05:00:00Z,2007,11,,,2012-03-14T00:27:33Z,,0,0,090000648044209e FDA-2007-P-0418-0001,FDA,FDA-2007-P-0418,FDA/DDM to Cobalt Laboratories Inc. and Cobalt Pharmaceuticals Inc.,Other,ACK-Acknowledgement Letter,2007-11-13T05:00:00Z,2007,11,,,2008-04-04T00:38:17Z,,0,0,090000648042da5d FDA-2005-V-0073-0003,FDA,FDA-2005-V-0073,Lynne L. Rice,Other,VRA-Approval for Variance,2007-11-13T05:00:00Z,2007,11,,,2008-04-12T00:31:15Z,,0,0,090000648043f32b FDA-1986-V-0022-0012,FDA,FDA-1986-V-0022,Variance Approval Letter from FDA CDRH to California Technical Associates,Other,Approval for Variance (VRA),2007-11-13T05:00:00Z,2007,11,,,2023-01-18T19:03:47Z,,0,0,090000648050dd54 FDA-2007-P-0418-0002,FDA,FDA-2007-P-0418,FDA/DDM to Cobalt Laboratories Inc. and Cobalt Pharmaceuticlas Inc,Other,ACK-Acknowledgement Letter,2007-11-13T05:00:00Z,2007,11,,,2008-04-04T00:38:17Z,,0,0,090000648042da64 FDA-2007-P-0118-0010,FDA,FDA-2007-P-0118,FDA/DDM to Shawn Bryant,Other,ACK-Acknowledgement Letter,2007-11-09T05:00:00Z,2007,11,,,2008-04-04T00:37:16Z,,0,0,0900006480429f7d FDA-2007-E-0048-0001,FDA,FDA-2007-E-0048,Schwarz Pharma Ltd. - Patent Term Extension Application,Other,APP-Application,2007-11-09T05:00:00Z,2007,11,,,2008-05-02T14:46:23Z,,0,0,090000648042967c FDA-2007-D-0133-0002,FDA,FDA-2007-D-0133,Guidance for Industry Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment - Guidance Document,Other,GDL-Guidance (Supporting and Related Materials),2007-11-09T05:00:00Z,2007,11,,,2008-05-16T22:52:27Z,,0,0,090000648042a2c2 FDA-2007-P-0118-0011,FDA,FDA-2007-P-0118,FDA/DDM to James Whalen,Other,ACK-Acknowledgement Letter,2007-11-09T05:00:00Z,2007,11,,,2008-04-04T00:37:16Z,,0,0,0900006480429f81