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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 072641

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NDA 072641 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Sun Pharma Canada, P And L, Novitium Pharma, Sciegen Pharms Inc, Teva, Tp Anda Holdings, Hikma, Padagis Us, Thinq Pharm-cro Pvt, Actavis Mid Atlantic, Glenmark Speclt, and Taro, and is included in nineteen NDAs. It is available from twenty-three suppliers. Additional details are available on the CLOTRIMAZOLE profile page.

The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for 072641

Tradename:	CLOTRIMAZOLE
Applicant:	Sun Pharma Canada
Ingredient:	clotrimazole
Patents:	0

Pharmacology for NDA: 072641

Medical Subject Heading (MeSH) Categories for 072641

14-alpha Demethylase Inhibitors
Anti-Infective Agents, Local
Antifungal Agents

Suppliers and Packaging for NDA: 072641

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE	clotrimazole	CREAM;VAGINAL	072641	ANDA	A-S Medication Solutions	50090-0614	50090-0614-0	1 TUBE in 1 CARTON (50090-0614-0) / 45 g in 1 TUBE
CLOTRIMAZOLE	clotrimazole	CREAM;VAGINAL	072641	ANDA	Sun Pharmaceutical Industries, Inc.	51672-2003	51672-2003-6	1 TUBE in 1 CARTON (51672-2003-6) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;VAGINAL			Strength	1%
Approval Date:	Dec 4, 1995	TE:		RLD:	No

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