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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 205991

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NDA 205991 describes ITRACONAZOLE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Rising, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Annora Pharma, and Apotex, and is included in fourteen NDAs. It is available from eleven suppliers. Additional details are available on the ITRACONAZOLE profile page.

The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for 205991

Tradename:	ITRACONAZOLE
Applicant:	Accord Hlthcare
Ingredient:	itraconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 205991

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	May 26, 2016	TE:		RLD:	No

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