Details for New Drug Application (NDA): 206837

NDA 206837 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Chartwell Rx, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-six NDAs. It is available from thirty-four 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-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

Summary for 206837

Tradename:	VORICONAZOLE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 206837

Mechanism of Action

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

Medical Subject Heading (MeSH) Categories for 206837

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 206837

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	TABLET;ORAL	206837	ANDA	NorthStar Rx LLC	16714-198	16714-198-01	30 TABLET, FILM COATED in 1 BOTTLE (16714-198-01)
VORICONAZOLE	voriconazole	TABLET;ORAL	206837	ANDA	NorthStar Rx LLC	16714-199	16714-199-01	30 TABLET, FILM COATED in 1 BOTTLE (16714-199-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jan 22, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 22, 2016	TE:	AB	RLD:	No

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