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FDA Drug Application 203109 by PFIZER

Application Number203109
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/30/2012N33628000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203109s000lbl.pdf 8/31/2012
AP08/30/2012N33632000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203109Orig1s000ltr.pdf 9/5/2012
AP08/30/2012N36742000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203109_revatio_toc.cfm 8/9/2013
AP08/30/2012N36743000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203109Orig1s000SumR.pdf 8/9/2013
AP03/11/2014SLR38779002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf 3/13/2014
AP03/11/2014SLR38784002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf 3/13/2014
AP01/31/2014SLR38425003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf 2/3/2014
AP01/31/2014SLR38448003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf 2/4/2014
AP01/31/2014SE838449004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf 2/4/2014
AP01/31/2014SE838426004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf 2/3/2014
AP03/6/2014SLR38719005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf 3/7/2014
AP03/6/2014SLR38722005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf 3/7/2014
AP01/12/2015SCM       
AP06/4/2015SCM       
AP04/27/2015SLR42690009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf 4/29/2015
AP04/27/2015SLR42776009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf 5/12/2015




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