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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020289
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GYNE-LOTRIMIN COMBINATION PACK CLOTRIMAZOLE 1%,100MG CREAM, TABLET;TOPICAL, 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
04/26/1993 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
02/22/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1998 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

03/06/1997 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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