Last Updated: November 8, 2026

Details for New Drug Application (NDA): 206410

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NDA 206410 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 is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for 206410

Tradename:	ITRACONAZOLE
Applicant:	Strides Pharma
Ingredient:	itraconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 206410

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:	Jul 2, 2019	TE:		RLD:	No

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