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FDA Drug Application 019950 by PFIZER

Application Number019950
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
AP01/29/1990N       
AP09/29/1992SCS       
AP010/13/1993SLR       
AP012/30/1993SE1       
AP010/13/1993SLR       
AP06/14/1993SCS       
AP02/10/1993SCS       
AP010/13/1993SLR       
AP06/22/1993SCM       
AP07/8/1994SCP       
AP011/23/1994SE5       
AP08/22/1994SCS       
AP06/30/1994SLR       
AP03/9/1995SCS       
AP03/20/1995SCS       
AP012/22/1995SCS       
AP07/23/1996SLR       
AP08/6/1996SLR       
AP02/19/1997SLR       
AP08/5/1997SLR       
AP02/13/1998SCM       
AP02/22/1999SLR       
AP09/29/1999SCM       
AP09/29/1999SCM       
AP010/7/2004SLR10387031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP010/7/2004SLR10396031   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       
AP010/7/2004SLR10397033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf 10/8/2004
AP010/7/2004SLR10388033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP08/7/2002SLR       
AP010/7/2004SLR10389037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP010/7/2004SLR10398037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf 10/8/2004
AP03/24/2004SLR8112039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf 3/28/2004
AP03/24/2004SLR8267039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf 4/5/2004
AP03/31/2008SLR19593043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf 4/4/2008
AP03/31/2008SLR19665043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf 4/16/2008
AP08/5/2010SLR26158053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf 8/10/2010
AP08/5/2010SLR26175053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf 8/10/2010
AP06/6/2011SLR29045056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019950s056lbl.pdf 6/6/2011
AP06/6/2011SLR29058056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf 6/8/2011
AP04/26/2011SLR28625057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf 4/29/2011
AP04/26/2011SLR28646057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf 4/29/2011
AP011/16/2011SLR30670059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf 11/21/2011
AP011/16/2011SLR30715059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf 11/21/2011
AP09/13/2013SLR37111061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf 9/17/2013
AP09/13/2013SLR37138061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf 9/17/2013
AP03/24/2014SLR38897062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf 3/25/2014
AP03/24/2014SLR38904062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf 3/25/2014
AP07/28/2014SCM       
AP06/1/2015SCM       




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