Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020421
Company: BAYER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FEMSTAT 3 BUTOCONAZOLE NITRATE 2% CREAM;VAGINAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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