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FDA Drug Application 204683 by OSMOTICA PHARM CORP

Application Number204683
Application Type New Drug Application
Sponsor ApplicantOSMOTICA PHARM CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/10/2013N36523000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s000lbl.pdf 7/11/2013
AP07/10/2013N36536000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s000ltr.pdf 7/12/2013
AP07/10/2013N36597000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362206.pdf 7/24/2013
AP07/10/2013N38692000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000TOC.cfm 3/6/2014
AP07/10/2013N38693000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000SumR.pdf 3/6/2014
AP010/1/2013SLR37271001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf 9/30/2013
AP010/1/2013SLR37297001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s001ltr.pdf 10/1/2013
AP07/16/2014SLR39885002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf 7/17/2014
AP07/16/2014SLR39892002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204683Orig1s002ltr.pdf 7/17/2014
AP09/6/2016SLR46987003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204683Orig1s003ltr.pdf 9/7/2016
AP09/6/2016SLR46999003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204683s003lbl.pdf 9/8/2016




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