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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 200463

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NDA 200463 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 200463

Tradename:	ITRACONAZOLE
Applicant:	Mylan Pharms Inc
Ingredient:	itraconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 200463

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 20, 2012	TE:		RLD:	No

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