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FDA Drug Application 050733 by PFIZER

Application Number050733
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
AP01/30/1997N4357000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050733ap.pdf 1/30/1997
AP01/30/1997N35408000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/12/2013
AP07/20/1999SLR       
AP010/19/1999SCM       
AP011/22/1999SCM       
AP011/11/2000SLR       
AP02/28/2001SLR5570005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50733s5lbl.pdf 5/2/2003
AP010/16/2002SLR2092006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733slr006ltr.pdf 10/16/2002
AP06/12/2003SLR5981007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50733slr007ltr.pdf 6/22/2003
AP012/10/2001SCM       
AP03/13/2002SCP2089009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733s9ltr.pdf 3/13/2002
AP07/22/2002SLR2081010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf 7/22/2002
AP01/15/2004SLR7603012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr012ltr.pdf 1/22/2004
AP01/15/2004SLR7604013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr013ltr.pdf 1/22/2004
AP010/25/2007SLR18330018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050733s018lbl.pdf 11/7/2007
AP010/25/2007SLR18399018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050733s018ltr.pdf 11/8/2007
AP02/27/2009SLR21938023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050733s023ltr.pdf 3/3/2009
AP02/27/2009SLR22183023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050733s023lbl.pdf 4/3/2009
AP08/11/2010SLR26233029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050733s029ltr.pdf 8/17/2010
AP08/11/2010SLR26257029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050733s029lbl.pdf 8/19/2010
AP01/28/2011SLR27692030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf 2/3/2011
AP01/28/2011SLR27737030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s030.pdf 2/4/2011
AP06/6/2014SLR39463031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050733Orig1s031ltr.pdf 6/10/2014
AP06/6/2014SLR39479031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050733s031lbl.pdf 6/10/2014
AP011/16/2011SLR30684033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050733s033ltr.pdf 11/21/2011
AP011/16/2011SLR30701033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s033lbl.pdf 11/21/2011
AP06/6/2012SLR32865034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf 6/8/2012
AP06/6/2012SLR32871034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf 6/11/2012
AP02/19/2013SLR35201035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050733Orig1s035ltr.pdf 2/21/2013
AP02/19/2013SLR35219035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050733s035lbl.pdf 2/21/2013
AP06/24/2014SCM       
AP05/24/2016SLR46147040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050733s040lbl.pdf 5/25/2016
AP05/24/2016SLR46157040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050733Orig1s040ltr.pdf 5/26/2016




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