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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 017619

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NDA 017619 describes LOTRIMIN, which is a drug marketed by Schering Plough, Schering, and Bayer Healthcare Llc, and is included in four NDAs. Additional details are available on the LOTRIMIN profile page.

The generic ingredient in LOTRIMIN is butenafine hydrochloride. There are two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the butenafine hydrochloride profile page.

Summary for 017619

Tradename:	LOTRIMIN
Applicant:	Schering Plough
Ingredient:	clotrimazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 017619

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017619

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering Plough	LOTRIMIN	clotrimazole	CREAM;TOPICAL	017619-001	Approved Prior to Jan 1, 1982	3,660,577	⤷ Get Started Free
Schering Plough	LOTRIMIN	clotrimazole	CREAM;TOPICAL	017619-001	Approved Prior to Jan 1, 1982	3,705,172	⤷ Get Started Free
Schering Plough	LOTRIMIN	clotrimazole	CREAM;TOPICAL	017619-001	Approved Prior to Jan 1, 1982	3,839,573	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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