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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216569

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NDA 216569 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 216569

Tradename:	CLOTRIMAZOLE
Applicant:	Sciegen Pharms Inc
Ingredient:	clotrimazole
Patents:	0

Pharmacology for NDA: 216569

Medical Subject Heading (MeSH) Categories for 216569

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

Suppliers and Packaging for NDA: 216569

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE	clotrimazole	SOLUTION;TOPICAL	216569	ANDA	ScieGen Pharmaceuticals, Inc	50228-502	50228-502-08	1 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLE
CLOTRIMAZOLE	clotrimazole	SOLUTION;TOPICAL	216569	ANDA	ScieGen Pharmaceuticals, Inc	50228-502	50228-502-30	1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	1%
Approval Date:	Oct 16, 2023	TE:	AT	RLD:	No

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