Back to FDA Applications sponsored by PFIZER

FDA Drug Application 022458 by PFIZER

Application Number022458
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/1/2012N32582000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf 5/2/2012
AP05/1/2012N32607000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf 5/3/2012
AP05/1/2012N32784000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022458Orig1s000TOC.cfm 6/4/2012
AP01/13/2014SCM       
AP05/14/2014SLR39311002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s002lbl.pdf 5/15/2014
AP05/14/2014SLR39324002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s002ltr.pdf 5/19/2014
AP08/27/2014SE840328003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf 8/28/2014
AP08/27/2014SE840334003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf 8/29/2014
AP06/24/2014SCM       
AP02/25/2016SCM       
AP08/27/2014SLR40329006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf 8/28/2014
AP08/27/2014SLR40335006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf 8/29/2014
AP011/20/2015SE844560007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022458Orig1s007ltr.pdf 11/23/2015
AP011/20/2015SE844587007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022458s007lbl.pdf 11/25/2015
AP012/23/2015SCM       
AP06/15/2016SLR46366012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022458Orig1s012ltr.pdf 6/21/2016
AP06/15/2016SLR46375012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s012lbl.pdf 6/21/2016




Back to FDA Applications sponsored by PFIZER