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FDA Drug Application 020883 by PFIZER

Application Number020883
Application Type New Drug Application
Sponsor ApplicantPFIZER
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
AP06/30/2000N543000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20883ltr.pdf 6/30/2000
AP06/30/2000N544000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20883lbl.pdf 6/30/2000
AP06/30/2000N4695000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-883_Acova.cfm 4/5/2002
AP08/22/2000SLR       
AP04/3/2002SE14546004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20883s4ltr.pdf 4/3/2002
AP04/3/2002SE14547004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20883s4lbl.pdf 4/3/2002
AP07/1/2002SCS       
AP010/29/2003SLR6903007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20883slr007ltr.pdf 11/13/2003
AP09/1/2005SLR12749009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s009ltr.pdf 9/8/2005
AP04/11/2005SLR11391010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020883s010ltr.pdf 4/12/2005
AP05/5/2008SE819789014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020883se8-014ltr.pdf 5/8/2008
AP05/5/2008SE819848014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020883s014lbl.pdf 5/19/2008
AP05/5/2008SE820222014   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020883se8-014_sumr.pdf 7/16/2008
AP01/26/2016SCM       
AP03/10/2014SLR38755016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020883Orig1s016ltr.pdf 3/11/2014
AP03/10/2014SLR38760016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020883s016lbl.pdf 3/11/2014
AP05/25/2016SLR46184018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020883Orig1s018ltr.pdf 5/27/2016
AP05/25/2016SLR46214018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020883s018lbl.pdf 6/1/2016




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