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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078338

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NDA 078338 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 078338

Tradename:	CLOTRIMAZOLE
Applicant:	Fougera Pharms
Ingredient:	clotrimazole
Patents:	0

Pharmacology for NDA: 078338

Medical Subject Heading (MeSH) Categories for 078338

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

Suppliers and Packaging for NDA: 078338

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	078338	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0133	0168-0133-15	15 g in 1 TUBE (0168-0133-15)
CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	078338	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0133	0168-0133-30	30 g in 1 TUBE (0168-0133-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Sep 2, 2008	TE:	AB	RLD:	No

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