Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020525
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GYNE-LOTRIMIN 3 CLOTRIMAZOLE 200MG TABLET;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
07/29/1996 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch 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
09/01/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/27/1997 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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