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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 215641

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NDA 215641 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Sun Pharma Canada, P And L, Novitium Pharma, Sciegen Pharms, 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-four 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 215641

Tradename:	CLOTRIMAZOLE
Applicant:	Thinq Pharm-cro Pvt
Ingredient:	clotrimazole
Patents:	0

Pharmacology for NDA: 215641

Medical Subject Heading (MeSH) Categories for 215641

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

Suppliers and Packaging for NDA: 215641

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE	clotrimazole	TROCHE/LOZENGE;ORAL	215641	ANDA	Rising Pharma Holdings, Inc.	16571-686	16571-686-07	70 LOZENGE in 1 BOTTLE (16571-686-07)
CLOTRIMAZOLE	clotrimazole	TROCHE/LOZENGE;ORAL	215641	ANDA	Rising Pharma Holdings, Inc.	16571-686	16571-686-14	140 LOZENGE in 1 BOTTLE (16571-686-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TROCHE/LOZENGE;ORAL			Strength	10MG
Approval Date:	Feb 29, 2024	TE:	AB	RLD:	No

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