Last Updated: May 14, 2026

Details for New Drug Application (NDA): 021946

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NDA 021946 describes XOLEGEL, which is a drug marketed by Ina Pharms and is included in one NDA. Additional details are available on the XOLEGEL profile page.

The generic ingredient in XOLEGEL is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 021946

Tradename:	XOLEGEL
Applicant:	Ina Pharms
Ingredient:	ketoconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 021946

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	2%
Approval Date:	Jul 28, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021946

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ina Pharms	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006	⤷ Start Trial	⤷ Start Trial
Ina Pharms	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006	⤷ Start Trial	⤷ Start Trial
Ina Pharms	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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