Details for New Drug Application (NDA): 216805

NDA 216805 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 216805

Tradename:	VORICONAZOLE
Applicant:	Zhejiang Poly Pharm
Ingredient:	voriconazole
Patents:	0

Pharmacology for NDA: 216805

Mechanism of Action

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

Medical Subject Heading (MeSH) Categories for 216805

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 216805

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	216805	ANDA	Slate Run Pharmaceuticals, LLC	70436-230	70436-230-39	1 BOTTLE in 1 CARTON (70436-230-39) / 75 mL in 1 BOTTLE
VORICONAZOLE	voriconazole	FOR SUSPENSION;ORAL	216805	ANDA	Zhejiang Poly Pharm Co., Ltd.	72673-111	72673-111-30	1 BOTTLE in 1 CARTON (72673-111-30) / 75 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML
Approval Date:	Jan 2, 2024	TE:	AB	RLD:	No

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