Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020288
Company: MEDTECH PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONISTAT 7 COMBINATION PACK MICONAZOLE NITRATE 2%,100MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter None Yes Yes
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
07/10/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/28/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/20/2000 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/04/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/26/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/21/1997 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/15/1996 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

MONISTAT 7 COMBINATION PACK

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CREAM, SUPPOSITORY;TOPICAL, VAGINAL; 2%,100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MONISTAT 7 COMBINATION PACK MICONAZOLE NITRATE 2%,100MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter Yes 020288 MEDTECH PRODUCTS

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