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FDA Drug Application 021674 by BAYER HLTHCARE

Application Number021674
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/8/2004N9306000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21674ltr.pdf 6/10/2004
AP06/8/2004N9319000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21674_menostar_lbl.pdf 6/10/2004
AP06/8/2004N13315000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021674_s000_MenostarTOC.cfm 1/3/2006
AP06/8/2004N44127000Approved Labeling 10/10/2013  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021674-10-2013lbl.pdf 10/6/2015




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