Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018520
Company: MEDTECH PRODUCTS

Products on NDA 018520

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONISTAT 7	MICONAZOLE NITRATE	100MG	SUPPOSITORY;VAGINAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/1982	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-24	Manufacturing (CMC)		Label is not available on this site.
03/26/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/17/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/08/1992	SUPPL-14	Labeling		Label is not available on this site.
06/03/1992	SUPPL-12	Labeling		Label is not available on this site.
02/15/1991	SUPPL-11	Efficacy-Rx To OTC Switch		Label is not available on this site.
09/11/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/04/1985	SUPPL-9	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/24/1985	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/24/1985	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/27/1983	SUPPL-5	Labeling		Label is not available on this site.
06/02/1983	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/20/1982	SUPPL-3	Labeling		Label is not available on this site.
05/13/1982	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/19/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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

MONISTAT 7

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

SUPPOSITORY;VAGINAL; 100MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MICONAZOLE NITRATE	MICONAZOLE NITRATE	100MG	SUPPOSITORY;VAGINAL	Over-the-counter	No	073507	P AND L
MONISTAT 7	MICONAZOLE NITRATE	100MG	SUPPOSITORY;VAGINAL	Over-the-counter	Yes	018520	MEDTECH PRODUCTS