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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020574

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NDA 020574 describes GYNE-LOTRIMIN 3, which is a drug marketed by Bayer Healthcare Llc and is included in three NDAs. Additional details are available on the GYNE-LOTRIMIN 3 profile page.

The generic ingredient in GYNE-LOTRIMIN 3 is clotrimazole. There are eleven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

Summary for 020574

Tradename:	GYNE-LOTRIMIN 3
Applicant:	Bayer Healthcare Llc
Ingredient:	clotrimazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 020574

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;VAGINAL			Strength	2%
Approval Date:	Nov 24, 1998	TE:		RLD:	Yes

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