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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 021308

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NDA 021308 describes MONISTAT 1 COMBINATION PACK, which is a drug marketed by Medtech Products and is included in one NDA. It is available from two suppliers. Additional details are available on the MONISTAT 1 COMBINATION PACK profile page.

The generic ingredient in MONISTAT 1 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for 021308

Tradename:	MONISTAT 1 COMBINATION PACK
Applicant:	Medtech Products
Ingredient:	miconazole nitrate
Patents:	0

Suppliers and Packaging for NDA: 021308

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308	NDA	CVS PHARMACY, INC	51316-093	51316-093-01	1 KIT in 1 PACKAGE, COMBINATION (51316-093-01) * 1 SUPPOSITORY in 1 POUCH (51316-094-01) * 9 g in 1 TUBE (51316-095-01)
MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308	NDA	Insight Pharmaceuticals LLC	63736-013	63736-013-30	1 KIT in 1 PACKAGE, COMBINATION (63736-013-30) * 9 g in 1 TUBE * 1 SUPPOSITORY in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM, INSERT;TOPICAL, VAGINAL			Strength	2%,1.2GM
Approval Date:	Jun 29, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021308

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001	5,514,698	⤷ Start Trial
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001	6,153,635	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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