Details for New Drug Application (NDA): 206799

NDA 206799 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Xellia Pharms Aps, Zydus Pharms, 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-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 206799

Tradename:	VORICONAZOLE
Applicant:	Novel Labs Inc
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 206799

Mechanism of Action

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

Medical Subject Heading (MeSH) Categories for 206799

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 206799

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	206799	ANDA	Novel Laboratories, Inc.	40032-038	40032-038-60	1 BOTTLE in 1 CARTON (40032-038-60) / 75 mL in 1 BOTTLE (40032-038-00)
VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	206799	ANDA	Lupin Pharmaceuticals,Inc.	43386-038	43386-038-60	1 BOTTLE in 1 CARTON (43386-038-60) / 75 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML
Approval Date:	May 31, 2016	TE:	AB	RLD:	No

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