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FDA Drug Application 020574 by BAYER HEALTHCARE LLC

Application Number020574
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
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
AP011/24/1998N83000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20574ltr.pdf 11/24/1998
AP011/24/1998N84000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20574lbl.pdf 11/24/1998
AP011/24/1998N2177000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-574_GyneLotrimin.cfm 11/24/1998
AP01/27/1999SCS       
AP09/1/2000SCM       
AP01/16/2002SCS       
AP04/12/2010SLR25254006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020574s006lbl.pdf 4/13/2010
AP04/12/2010SLR25257006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020574s006ltr.pdf 4/13/2010




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