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FDA Drug Application 021317 by BAYER

Application Number021317
Application Type New Drug Application
Sponsor ApplicantBAYER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/18/2001N3828000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21317ltr.pdf 10/18/2001
AP010/18/2001N3829000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21317lbl.pdf 10/18/2001
AP010/18/2001N3830000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21317_Bayer.cfm 10/18/2001




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