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FDA Drug Application 021490 by APIL

Application Number021490
Application Type New Drug Application
Sponsor ApplicantAPIL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/14/2003N6906000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf 11/14/2003
AP011/14/2003N6997000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21490ltr.pdf 11/28/2003
AP011/14/2003N11065000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-490_NorethinOvcon.cfm 2/2/2005
AP01/29/2007SCS15733005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf 2/2/2007
AP01/29/2007SCS15783005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021490s005ltr.pdf 2/12/2007
AP01/9/2008SLR18874007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021490s007ltr.pdf 1/15/2008
AP01/9/2008SLR18898007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf 1/18/2008
AP09/22/2016SLR47195010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf 9/29/2016
AP09/22/2016SLR47335010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021490Orig1s010ltr.pdf 10/12/2016
AP03/1/2013SCM       
AP08/6/2013SCM       
AP01/5/2015SCM       
AP09/3/2015SCM       
AP012/22/2015SCM       
AP07/8/2016SCM       




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