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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 208481

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NDA 208481 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 fifteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for 208481

Tradename:	ITRACONAZOLE
Applicant:	Apotex
Ingredient:	itraconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 208481

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Aug 2, 2019	TE:		RLD:	No

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