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Last Updated: April 10, 2026

Details for New Drug Application (NDA): 091658

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NDA 091658 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, Novel Labs Inc, Rising, Zhejiang Poly Pharm, Almaject, Aspiro, Eugia Pharma, Gland, Hikma, Meitheal, Pharmobedient, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Hainan Poly Pharm, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-eight NDAs. It is available from thirty-one suppliers. Additional details are available on the VORICONAZOLE profile page.

The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 091658

Tradename:	VORICONAZOLE
Applicant:	Teva Pharms
Ingredient:	voriconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 091658

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 6, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Apr 6, 2012	TE:		RLD:	No

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