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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209815

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NDA 209815 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 209815

Tradename:	CLOTRIMAZOLE
Applicant:	Novitium Pharma
Ingredient:	clotrimazole
Patents:	0

Pharmacology for NDA: 209815

Medical Subject Heading (MeSH) Categories for 209815

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

Suppliers and Packaging for NDA: 209815

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE	clotrimazole	SOLUTION;TOPICAL	209815	ANDA	Novitium Pharma LLC	70954-036	70954-036-20	1 BOTTLE in 1 CARTON (70954-036-20) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	1%
Approval Date:	Feb 14, 2019	TE:	AT	RLD:	No

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