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FDA Drug Application 022247 by WYETH PHARMS PFIZER

Application Number022247
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS PFIZER
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
AP010/3/2013N37587000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247s000lbl.pdf 10/25/2013
AP010/3/2013N37819000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022247_duavee_toc.cfm 11/15/2013
AP010/3/2013N37878001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf 11/21/2013
AP17/27/2015SLR37878001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf 11/21/2013
AP010/3/2013N37540001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022247Orig1s001ltr.pdf 10/24/2013
AP17/27/2015SLR37540001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022247Orig1s001ltr.pdf 10/24/2013
AP09/25/2015SLR44003002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022247Orig1s002ltr.pdf 9/28/2015
AP09/25/2015SLR44152002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022247s002lbl.pdf 10/7/2015




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