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FDA Drug Application 203312 by IMPAX LABS INC

Application Number203312
Application Type New Drug Application
Sponsor ApplicantIMPAX LABS INC
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
AP01/7/2015N41520000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203312s000lbl.pdf 1/8/2015
AP01/7/2015N41528000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf 1/8/2015
AP01/7/2015N46338000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203312Orig1s000TOC.cfm 6/15/2016
AP01/7/2015N46339000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203312Orig1s000SumR.pdf 6/15/2016
AP012/14/2015SCM       
AP012/14/2015SCM       
AP04/13/2016SCM       
AP06/3/2016SCM       
AP010/1/2016SCM       
AP010/27/2016SLR47538006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203312Orig1s006ltr.pdf 10/31/2016
AP010/14/2016SCM       




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