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FDA Drug Application 019949 by PFIZER

Application Number019949
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority*
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/29/1990N       
AP08/20/1992SCM       
AP010/13/1993SLR       
AP012/30/1993SE1       
AP010/13/1993SLR       
AP06/14/1993SCS       
AP010/13/1993SLR       
AP011/23/1994SE5       
AP05/24/1995SCF       
AP06/30/1994SLR       
AP012/22/1995SCS       
AP09/11/1995SCM       
AP09/11/1995SCM       
AP07/23/1996SLR       
AP08/6/1996SLR       
AP05/2/1997SCP       
AP02/19/1997SLR       
AP08/5/1997SLR       
AP02/18/1998SCS       
AP02/22/1999SLR       
AP09/27/1999SCM       
AP03/1/2000SCP       
AP010/7/2004SLR10384030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP010/7/2004SLR10399030   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       
AP010/7/2004SLR10400032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf 10/8/2004
AP010/7/2004SLR10385032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP08/7/2002SLR1685033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf 8/7/2002
AP08/7/2002SLR4783033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19949slr033,19950slr033,20090slr015ltr.pdf 8/7/2002
AP010/7/2004SLR10386035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf 10/8/2004
AP010/7/2004SLR10401035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf 10/8/2004
AP03/24/2004SLR8111037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf 3/28/2004
AP03/24/2004SLR8266037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf 4/5/2004
AP03/31/2008SLR19592041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf 4/4/2008
AP03/31/2008SLR19664041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf 4/16/2008
AP08/5/2010SLR26157048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf 8/10/2010
AP08/5/2010SLR26176048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf 8/10/2010
AP06/6/2011SLR29044051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s051lbl.pdf 6/6/2011
AP06/6/2011SLR29057051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf 6/8/2011
AP04/26/2011SLR28624052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf 4/29/2011
AP04/26/2011SLR28647052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf 4/29/2011
AP011/16/2011SLR30669055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf 11/21/2011
AP011/16/2011SLR30714055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf 11/21/2011
AP09/13/2013SLR37112057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf 9/17/2013
AP09/13/2013SLR37137057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf 9/17/2013
AP03/24/2014SLR38898058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf 3/25/2014
AP03/24/2014SLR38903058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf 3/25/2014
AP07/28/2014SCM       
AP010/30/2014SLR40913060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1s060,020090orig1s044ltr.pdf 10/31/2014
AP010/30/2014SLR40934060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf 11/4/2014
AP05/29/2015SCM       
AP05/2/2016SCM       
AP06/6/2016SCM       




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