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FDA Drug Application 022030 by PFIZER

Application Number022030
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
AP010/31/2008N21178000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022030s000ltr.pdf 11/7/2008
AP010/31/2008N21190000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022030lbl.pdf 11/7/2008
AP010/31/2008N21912000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022030s000TOC.cfm 2/26/2009
AP010/31/2008N21913000   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022030s000_SumR.pdf 2/26/2009
AP04/2/2010SLR25189004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022030s004lbl.pdf 4/4/2010
AP04/2/2010SLR25236004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022030s004ltr.pdf 4/8/2010
AP011/1/2011SLR30486006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s006ltr.pdf 11/3/2011
AP011/1/2011SLR30654006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s006lbl.pdf 11/18/2011
AP02/10/2011SLR27820007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s007lbl.pdf 2/11/2011
AP02/10/2011SLR27831007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s007ltr.pdf 2/14/2011
AP012/30/2011SLR31332008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s008ltr.pdf 1/3/2012
AP012/30/2011SLR31358008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s008lbl.pdf 1/6/2012
AP08/1/2012SLR33344009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022030s009lbl.pdf 8/2/2012
AP08/1/2012SLR33350009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022030Orig1s009ltr.pdf 8/3/2012
AP08/13/2014SCM       
AP01/23/2013SCM       




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