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FDA Drug Application 022501 by APIL

Application Number022501
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
AP010/21/2010N26760000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf 10/25/2010
AP010/21/2010N26777000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022501s000ltr.pdf 10/26/2010
AP010/21/2010N28795000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501_lo_loestrin_fe_toc.cfm 5/13/2011
AP010/21/2010N28796000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501Orig1s000SumR.pdf 5/13/2011
AP03/1/2013SCM       
AP05/8/2013SCM       




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