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FDA Drug Application 011795 by PFIZER

Application Number011795
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
AP06/3/1959N       
AP012/2/1974SDS       
AP06/6/1975SCS       
AP05/21/1979SLR       
AP08/30/2000SLR       
AP03/21/2001SLR1409018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF 3/21/2001
AP07/20/2000SCM       
AP012/24/2004SLR10813020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr.pdf 12/29/2004
AP06/3/2014SLR39442025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf 6/4/2014
AP06/3/2014SLR39452025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795Orig1s025ltr.pdf 6/5/2014
AP02/18/2016SLR45222027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795Orig1s027ltr.pdf 2/22/2016
AP02/18/2016SLR45409027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf 3/10/2016




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