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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018040

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NDA 018040 describes MONISTAT, which is a drug marketed by Janssen Pharma, Medtech Products, Personal Prods, and Insight Pharms, and is included in twelve NDAs. Additional details are available on the MONISTAT profile page.

The generic ingredient in MONISTAT is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for 018040

Tradename:	MONISTAT
Applicant:	Janssen Pharma
Ingredient:	miconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 018040

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 018040

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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