Last Updated: June 17, 2026

Details for New Drug Application (NDA): 018181

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NDA 018181 describes MYCELEX, which is a drug marketed by Bayer Healthcare Llc, Bayer Hlthcare, and Bayer Pharms, and is included in seven NDAs. Additional details are available on the MYCELEX profile page.

The generic ingredient in MYCELEX is clotrimazole. There are eleven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

Summary for 018181

Tradename:	MYCELEX
Applicant:	Bayer Hlthcare
Ingredient:	clotrimazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 018181

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 018181

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982	3,660,577	⤷ Start Trial
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982	3,839,573	⤷ Start Trial
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982	3,705,172	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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