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FDA Drug Application 021876 by DUCHESNAY

Application Number021876
Application Type New Drug Application
Sponsor ApplicantDUCHESNAY
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
AP04/8/2013N35669000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021876Orig1s000ltr.pdf 4/10/2013
AP04/8/2013N35727000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf 4/16/2013
AP04/8/2013N38906000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000TOC.cfm 3/25/2014
AP04/8/2013N38907000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000SumR.pdf 3/25/2014
AP01/29/2014SCM       
AP09/30/2013SCM37277002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf 9/30/2013
AP03/28/2014SCM       
AP07/30/2014SCM       
AP011/24/2014SCM       
AP012/16/2014SLR41285006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021876Orig1s006ltr.pdf 12/17/2014
AP06/23/2015SCM       
AP09/10/2015SCM       
AP03/10/2016SCM       




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