Details for New Drug Application (NDA): 206654

NDA 206654 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 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-one suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 206654

Tradename:	VORICONAZOLE
Applicant:	Prinston Inc
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 206654

Mechanism of Action

Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 206654

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 206654

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	TABLET;ORAL	206654	ANDA	Solco Healthcare U.S., LLC	43547-377	43547-377-03	30 TABLET, COATED in 1 BOTTLE (43547-377-03)
VORICONAZOLE	voriconazole	TABLET;ORAL	206654	ANDA	Solco Healthcare U.S., LLC	43547-377	43547-377-50	500 TABLET, COATED in 1 BOTTLE (43547-377-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 8, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 8, 2016	TE:	AB	RLD:	No

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