Details for New Drug Application (NDA): 021261

NDA 021261 describes MONISTAT 3 COMBINATION PACK (PREFILLED), which is a drug marketed by Medtech Products and is included in one NDA. It is available from one supplier. Additional details are available on the MONISTAT 3 COMBINATION PACK (PREFILLED) profile page.

The generic ingredient in MONISTAT 3 COMBINATION PACK (PREFILLED) is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for 021261

Tradename:	MONISTAT 3 COMBINATION PACK (PREFILLED)
Applicant:	Medtech Products
Ingredient:	miconazole nitrate
Patents:	0

Suppliers and Packaging for NDA: 021261

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261	NDA	Insight Pharmaceuticals LLC	63736-010	63736-010-01	1 KIT in 1 PACKAGE, COMBINATION (63736-010-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE
MONISTAT 3 COMBINATION PACK (PREFILLED)	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261	NDA	Insight Pharmaceuticals LLC	63736-010	63736-010-01	1 KIT in 1 PACKAGE, COMBINATION (63736-010-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL, VAGINAL			Strength	2%,4%
Approval Date:	Feb 2, 2001	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;TOPICAL, VAGINAL			Strength	2%,4%
Approval Date:	Jun 17, 2003	TE:		RLD:	Yes

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