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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020288
Company: MEDTECH PRODUCTS

Products on NDA 020288

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020288

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.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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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