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FDA Drug Application 011459 by PFIZER

Application Number011459
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/15/1968N       
AP012/2/1974SCS       
AP05/21/1979SLR       
AP011/28/1994SCM       
AP08/30/2000SLR       
AP03/21/2001SLR4561036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF 3/21/2001
AP03/27/2000SCP       
AP06/13/2000SCM       
AP012/24/2004SLR10812039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr.pdf 12/29/2004
AP06/3/2014SLR39443048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf 6/4/2014
AP06/3/2014SLR39451048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795Orig1s025ltr.pdf 6/5/2014
AP02/18/2016SLR45221050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795Orig1s027ltr.pdf 2/22/2016
AP02/18/2016SLR45408050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf 3/10/2016




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