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FDA Drug Application 019885 by PFIZER PHARMS

Application Number019885
Application Type New Drug Application
Sponsor ApplicantPFIZER PHARMS
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
AP011/19/1991N14279000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP010/29/1993SE1       
AP05/7/1992SLR       
AP010/12/1994SLR       
AP05/26/1993SLR       
AP04/12/1996SLR       
AP011/20/1995SCM       
AP011/1/1995SCS       
AP011/2/1995SCS       
AP06/18/1996SCM       
AP07/3/1996SLR       
AP07/1/1997SCM       
AP07/2/1997SCM       
AP07/3/1997SCS       
AP02/25/1998SLR       
AP05/4/1998SCS       
AP09/10/1999SCM       
AP04/17/2001SLR1394018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19885S18ltr.pdf 4/17/2001
AP07/22/2002SLR6238019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19885slr019ltr.pdf 7/30/2003
AP06/21/2001SLR       
AP012/13/2002SCS       
AP010/29/2003SLR6872023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf 11/5/2003
AP09/18/2009SLR23510028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf 10/1/2009
AP09/18/2009SLR23839028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019885s028ltr.pdf 11/12/2009
AP010/14/2011SLR30338033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019885s033ltr.pdf 10/18/2011
AP010/14/2011SLR30378033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf 10/20/2011
AP01/18/2012SLR31426035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf 1/23/2012
AP01/18/2012SLR31464035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf 1/23/2012
AP09/21/2012SLR33835036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf 9/25/2012
AP04/9/2013SLR35680037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s037ltr.pdf 4/11/2013
AP04/9/2013SLR35731037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf 4/16/2013
AP09/23/2013SLR37194038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf 9/23/2013
AP09/23/2013SLR37206038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s038ltr.pdf 9/24/2013
AP010/25/2013SLR37592039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s039ltr.pdf 10/28/2013
AP010/25/2013SLR37654039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf 10/31/2013
AP05/2/2014SLR39219040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019885Orig1s040ltr.pdf 5/6/2014
AP05/2/2014SLR39224040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf 5/6/2014
AP09/11/2015SLR43863041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019885Orig1s041ltr.pdf 9/14/2015
AP09/11/2015SLR43867041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf 9/14/2015




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