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FDA Drug Application 021992 by WYETH PHARMS INC

Application Number021992
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/29/2008N19370000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021992lbl.pdf 3/5/2008
AP02/29/2008N19383000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021992s000ltr.pdf 3/5/2008
AP02/29/2008N19999000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021992s000TOC.cfm 6/13/2008
AP02/29/2008N24877000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088985.pdf 3/1/2010
AP08/31/2009SLR24125001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf 11/24/2009
AP08/31/2009SLR23744001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf 11/5/2009
AP01/30/2009SLR21718004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s004ltr.pdf 2/3/2009
AP01/30/2009SLR21786004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s004lbl.pdf 2/4/2009
AP04/23/2009SCS22341005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s005lbl.pdf 4/28/2009
AP04/23/2009SCS22359005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s005ltr.pdf 4/29/2009
AP08/31/2009SLR23403006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf 9/18/2009
AP08/31/2009SLR24126006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf 11/24/2009
AP08/31/2009SLR24127007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s001,006,007ltr.pdf 11/24/2009
AP08/31/2009SLR23404007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s001s006s007lbl.pdf 9/18/2009
AP011/9/2009SLR24609008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s008ltr.pdf 1/25/2010
AP011/9/2009SLR23925009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021992s009lbl.pdf 11/17/2009
AP011/9/2009SLR24608009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021992s009ltr.pdf 1/25/2010
AP02/16/2010SLR24807011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s011lbl.pdf 2/17/2010
AP02/16/2010SLR24824011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s011ltr.pdf 2/22/2010
AP010/18/2010SLR26677013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s013lbl.pdf 10/18/2010
AP010/18/2010SLR26722013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s013ltr.pdf 10/20/2010
AP07/9/2010SLR25957015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s015lbl.pdf 7/12/2010
AP07/9/2010SLR25966015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s015ltr.pdf 7/14/2010
AP09/8/2010SLR26433017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s017ltr.pdf 9/9/2010
AP09/8/2010SLR26450017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s017lbl.pdf 9/10/2010
AP012/29/2010SLR27495019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021992s019lbl.pdf 1/10/2011
AP012/29/2010SLR27598019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021992s019ltr.pdf 1/25/2011
AP01/31/2011S27681020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s020lbl.pdf 1/31/2011
AP01/31/2011S27700020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s020ltr.pdf 2/3/2011
AP03/4/2011SLR28107021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s021ltr.pdf 3/7/2011
AP03/4/2011SLR28127021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s021lbl.pdf 3/7/2011
AP04/11/2011SLR28522022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021992s022lbl.pdf 4/11/2011
AP04/11/2011SLR28537022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021992s022ltr.pdf 4/13/2011
AP03/7/2012SLR32078030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s030lbl.pdf 3/9/2012
AP03/7/2012SLR32080030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021992s030ltr.pdf 3/12/2012
AP012/10/2013SLR38002031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s031lbl.pdf 12/11/2013
AP012/10/2013SLR38023031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s031ltr.pdf 12/13/2013
AP02/14/2013SE135181033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s033,s036ltr.pdf 2/19/2013
AP02/14/2013SE135188033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf 2/20/2013
AP012/7/2012SLR34571034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021992s034lbl.pdf 12/10/2012
AP012/7/2012SLR34593034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021992Orig1s034ltr.pdf 12/11/2012
AP04/19/2013SCM       
AP02/14/2013SLR35189036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s033s036lbl.pdf 2/20/2013
AP02/14/2013SLR35457036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s033,s036ltr.pdf 3/15/2013
AP012/23/2013SLR38160037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021992Orig1s037ltr.pdf 12/24/2013
AP012/23/2013SLR38170037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021992s037lbl.pdf 12/24/2013
AP08/20/2014N40996039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021992Orig1s039ltr.pdf 11/14/2014
AP08/20/2014N41006039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992Orig1s039lbl.pdf 11/17/2014
AP07/17/2014SLR39899040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021992Orig1s040ltr.pdf 7/21/2014
AP07/17/2014SLR40054040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021992s040lbl.pdf 7/29/2014
AP03/16/2016SCM       
AP08/26/2016SLR46893043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021992Orig1s043ltr.pdf 8/29/2016
AP08/26/2016SLR46913043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021992s043lbl.pdf 8/29/2016




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