Last Updated: November 14, 2026

Details for New Drug Application (NDA): 021360

NDA 021360 describes SUSTIVA, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. Additional details are available on the SUSTIVA profile page.

The generic ingredient in SUSTIVA is efavirenz. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the efavirenz profile page.

Summary for 021360

Tradename:	SUSTIVA
Applicant:	Bristol Myers Squibb
Ingredient:	efavirenz
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 1, 2002	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 1, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021360

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,633,169	⤷ Start Trial
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-002	Feb 1, 2002	5,811,423	⤷ Start Trial
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,811,423	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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