Details for New Drug Application (NDA): 021567

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NDA 021567 describes REYATAZ, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the REYATAZ profile page.

The generic ingredient in REYATAZ 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 021567

Tradename:	REYATAZ
Applicant:	Bristol Myers Squibb
Ingredient:	atazanavir sulfate
Patents:	0

Pharmacology for NDA: 021567

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 021567

HIV Protease Inhibitors

Suppliers and Packaging for NDA: 021567

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567	NDA	E.R. Squibb & Sons, L.L.C.	0003-3622	0003-3622-12	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12)
REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567	NDA	E.R. Squibb & Sons, L.L.C.	0003-3631	0003-3631-12	60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3631-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 20, 2003	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 20, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Jun 20, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021567

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-002	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-002	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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