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FDA Drug Application 205122 by UPSHER-SMITH LABS

Application Number205122
Application Type New Drug Application
Sponsor ApplicantUPSHER-SMITH LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/11/2014N38781000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205122Orig1s000ltr.pdf 3/13/2014
AP03/11/2014N38793000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205122s000lbl.pdf 3/13/2014
AP03/11/2014N42821000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205122Orig1s000TOC.cfm 5/14/2015
AP03/11/2014N42822000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205122Orig1s000SumR.pdf 5/14/2015
AP03/30/2015SE842365001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205122s001lbl.pdf 4/1/2015
AP03/30/2015SE842371001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205122Orig1s001ltr.pdf 4/2/2015
AP06/16/2015SCM       
AP04/15/2016TA45708003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205122Orig1s003TAltr.pdf 4/20/2016




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