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FDA Drug Application 020090 by PFIZER

Application Number020090
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard*
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1993N       
AP03/22/1994SLR       
AP06/30/1994SLR       
AP02/21/1995SLR       
AP02/21/1995SLR       
AP012/22/1995SCS       
AP07/23/1996SLR       
AP08/6/1996SLR       
AP02/19/1997SLR       
AP08/5/1997SLR       
AP02/22/1999SLR       
AP010/7/2004SLR10390012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP010/7/2004SLR10393012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf 10/8/2004
AP03/5/2001SCS       
AP010/7/2004SLR10391014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP010/7/2004SLR10394014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf 10/8/2004
AP08/7/2002SLR1686015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf 8/7/2002
AP08/7/2002SLR4784015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19949slr033,19950slr033,20090slr015ltr.pdf 8/7/2002
AP010/7/2004SLR10392017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP010/7/2004SLR10395017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf 10/8/2004
AP03/24/2004SLR8113019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf 3/28/2004
AP03/24/2004SLR8268019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf 4/5/2004
AP03/31/2008SLR19594022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf 4/4/2008
AP03/31/2008SLR19666022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf 4/16/2008
AP08/5/2010SLR26159031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf 8/10/2010
AP08/5/2010SLR26174031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf 8/10/2010
AP06/6/2011SLR29046034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020090s034lbl.pdf 6/6/2011
AP06/6/2011SLR29059034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf 6/8/2011
AP04/26/2011SLR28626036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf 4/29/2011
AP04/26/2011SLR28645036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf 4/29/2011
AP011/16/2011SLR30671038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf 11/21/2011
AP011/16/2011SLR30716038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf 11/21/2011
AP09/13/2013SLR37110040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf 9/17/2013
AP09/13/2013SLR37139040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf 9/17/2013
AP01/7/2014SCM       
AP03/24/2014SLR38896042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf 3/25/2014
AP03/24/2014SLR38905042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf 3/25/2014
AP07/28/2014SCM       
AP010/30/2014SLR40914044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1s060,020090orig1s044ltr.pdf 10/31/2014
AP010/30/2014SLR40933044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf 11/4/2014




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