Details for New Drug Application (NDA): 212278

NDA 212278 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 212278

Tradename:	ATAZANAVIR SULFATE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	atazanavir sulfate
Patents:	0

Pharmacology for NDA: 212278

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 212278

HIV Protease Inhibitors

Suppliers and Packaging for NDA: 212278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	212278	ANDA	Camber Pharmaceuticals, Inc.	31722-653	31722-653-10	1000 CAPSULE in 1 BOTTLE (31722-653-10)
ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	212278	ANDA	Camber Pharmaceuticals, Inc.	31722-653	31722-653-31	100 BLISTER PACK in 1 CARTON (31722-653-31) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Feb 2, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Feb 2, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Feb 2, 2022	TE:	AB	RLD:	No

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