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FDA Drug Application 205919 by NOVA LABS LTD

Application Number205919
Application Type New Drug Application
Sponsor ApplicantNOVA LABS LTD
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
AP04/28/2014N39151000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205919s000lbl.pdf 4/28/2014
AP04/28/2014N39161000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s000ltr.pdf 4/29/2014
AP04/28/2014N41309000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205919Orig1s000TOC.cfm 12/18/2014
AP012/23/2014SCM41459001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s001ltr.pdf 12/31/2014




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