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FDA Drug Application 021016 by PFIZER IRELAND

Application Number021016
Application Type New Drug Application
Sponsor ApplicantPFIZER IRELAND
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
AP012/26/2002N3129000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21016ltr.pdf 1/29/2003
AP012/26/2002N4969000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21016_relpax_lbl.pdf 4/7/2003
AP012/26/2002N7012000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21016_Relpax.cfm 12/2/2003
AP012/26/2002N15672000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 1/17/2007
AP05/6/2004SLR8554003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21016slr003ltr.pdf 5/7/2004
AP07/21/2010SLR26013009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf 7/23/2010
AP07/21/2010SLR26059009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf 7/31/2010
AP07/21/2010SLR26060016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf 7/31/2010
AP111/27/2013SCM26060016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf 7/31/2010
AP07/21/2010SLR26014016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf 7/23/2010
AP111/27/2013SCM26014016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf 7/23/2010
AP04/13/2011SLR28545018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021016s018ltr.pdf 4/15/2011
AP04/13/2011SLR28556018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021016s018lbl.pdf 4/15/2011
AP010/3/2013SLR37369021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf 10/8/2013
AP010/3/2013SLR37382021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf 10/8/2013
AP010/3/2013SLR37383023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf 10/8/2013
AP010/3/2013SLR37370023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf 10/8/2013
AP010/3/2013SLR37371024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf 10/8/2013
AP010/3/2013SLR37384024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf 10/8/2013
AP011/7/2013SCM       
AP012/3/2013SCM       
AP010/3/2013SLR37385027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf 10/8/2013
AP010/3/2013SLR37372027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf 10/8/2013
AP09/18/2015SCM       




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