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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 021360


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NDA 021360 describes SUSTIVA, 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 SUSTIVA profile page.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-six drug master file entries for this compound. Eight 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
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021360
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSTIVA efavirenz TABLET;ORAL 021360 NDA Bristol-Myers Squibb Pharma Company 0056-0510 0056-0510-30 30 TABLET, FILM COATED in 1 BOTTLE (0056-0510-30)
Paragraph IV (Patent) Challenges for 021360
Tradename Dosage Ingredient NDA Submissiondate
SUSTIVA TABLET;ORAL efavirenz 021360 2009-04-09

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 1, 2002TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 1, 2002TE:ABRLD:Yes

Expired US Patents for NDA 021360

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

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