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FDA Drug Application 203826 by WEST WARD PHARM CORP

Application Number203826
Application Type New Drug Application
Sponsor ApplicantWEST WARD PHARM CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2012N34748000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203826s000lbl.pdf 12/21/2012
AP012/20/2012N34756000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203826Orig1s000ltr.pdf 12/26/2012
AP012/20/2012N36136000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826_phenylephrine_toc.cfm 5/24/2013
AP012/20/2012N36137000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826Orig1s000SumR.pdf 5/24/2013
AP09/6/2016SLR46993002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203826Orig1s002ltr.pdf 9/8/2016
AP09/6/2016SLR47021002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203826s002lbl.pdf 9/12/2016
AP010/23/2014SCM       
AP02/16/2015SCM       




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