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FDA Drug Application 021633 by APIL

Application Number021633
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
AP08/20/2004N10034000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21633ltr.pdf 8/25/2004
AP08/20/2004N13193000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021633s000_FemtraceTOC.cfm 12/1/2005
AP08/12/2014SLR40224005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021633s005lbl.pdf 8/13/2014
AP08/12/2014SLR40229005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021633Orig1s005ltr.pdf 8/14/2014




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