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FDA Drug Application 202236 by MEDA PHARMS

Application Number202236
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/1/2012N32597000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s000lbl.pdf 5/2/2012
AP05/1/2012N32605000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236s000ltr.pdf 5/3/2012
AP05/1/2012N35942000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202236_dymista_toc.cfm 5/6/2013
AP05/1/2012N35943000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202236Orig1s000SumR.pdf 5/6/2013
AP08/10/2012SLR33493001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236Orig1s001ltr.pdf 8/17/2012
AP08/10/2012SLR33543001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s001lbl.pdf 8/22/2012
AP011/19/2012SCM       
AP03/26/2013SCM       
AP01/21/2014SCM       
AP06/2/2014SCM       
AP010/29/2014SCM       
AP02/20/2015SE841889008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202236s008lbl.pdf 2/23/2015
AP02/20/2015SE841899008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202236Orig1s008ltr.pdf 2/24/2015




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