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FDA Drug Application 021134 by PFIZER PHARMS

Application Number021134
Application Type New Drug Application
Sponsor ApplicantPFIZER PHARMS
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
AP05/1/2000N1281000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21134ltr.pdf 5/1/2000
AP05/1/2000N1282000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21134lbl.pdf 5/1/2000
AP05/1/2000N2974000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat.cfm 5/1/2000
AP07/12/2010SLR25986004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021134s004ltr.pdf 7/21/2010
AP07/12/2010SLR25989004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021134s004lbl.pdf 7/22/2010
AP07/21/2011SLR29585005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021134s005ltr.pdf 7/25/2011
AP07/21/2011SLR29592005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021134s005lbl.pdf 7/25/2011
AP03/7/2014SLR38727007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021134Orig1s007ltr_corrected.pdf 3/10/2014
AP03/7/2014SLR38737007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021134s007lbl.pdf 3/10/2014
AP08/26/2016SLR46912008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021134s008lbl.pdf 8/29/2016
AP08/26/2016SLR46927008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021134Orig1s008ltr.pdf 8/30/2016




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