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FDA Drug Application 203667 by APIL

Application Number203667
Application Type New Drug Application
Sponsor ApplicantAPIL
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
AP05/8/2013N36022000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s000ltr.pdf 5/10/2013
AP05/8/2013N36062000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s000lbl.pdf 5/14/2013
AP05/8/2013N37176000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667_norethindrone_toc.cfm 9/20/2013
AP05/8/2013N37177000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667Orig1s000SumR.pdf 9/20/2013
AP011/19/2013SCM       
AP07/11/2013SLR36537002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s002ltr.pdf 7/12/2013
AP07/11/2013SLR36554002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s002lbl.pdf 7/12/2013
AP04/14/2014SCM       
AP012/5/2014SLR41180004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203667Orig1s004ltr.pdf 12/9/2014
AP012/5/2014SLR41275004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203667s004lbl.pdf 12/16/2014
AP09/3/2015SCM       
AP08/1/2016SCM       




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