Details for New Drug Application (NDA): 091673

NDA 091673 describes ATAZANAVIR SULFATE, which is a drug marketed by Amneal, Aurobindo Pharma, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, and Zydus Pharms, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the ATAZANAVIR SULFATE profile page.

The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.

Summary for 091673

Tradename:	ATAZANAVIR SULFATE
Applicant:	Teva Pharms Usa
Ingredient:	atazanavir sulfate
Patents:	0

Pharmacology for NDA: 091673

Mechanism of Action

Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

Medical Subject Heading (MeSH) Categories for 091673

HIV Protease Inhibitors

Suppliers and Packaging for NDA: 091673

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	091673	ANDA	Teva Pharmaceuticals USA, Inc.	0093-5526	0093-5526-06	60 CAPSULE in 1 BOTTLE (0093-5526-06)
ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	091673	ANDA	Teva Pharmaceuticals USA, Inc.	0093-5527	0093-5527-06	60 CAPSULE in 1 BOTTLE (0093-5527-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Apr 22, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Apr 22, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Apr 22, 2014	TE:	AB	RLD:	No

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