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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 four suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SUSTIVA profile page.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-four drug master file entries for this compound. Four suppliers are listed for this compound. There are thirty-six tentative approvals for this compound. Additional details are available on the efavirenz profile page.

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)
SUSTIVA
efavirenz
TABLET;ORAL 021360 NDA REMEDYREPACK INC. 24236-282 24236-282-02 30 TABLET, FILM COATED in 1 BLISTER PACK (24236-282-02)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:6,639,071*PEDPatent Expiration:Aug 14, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,939,964*PEDPatent Expiration:Jul 20, 2018Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 1, 2002TE:ABRLD:Yes
Patent:6,639,071*PEDPatent Expiration:Aug 14, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021360

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 20025,811,423► subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 20025,519,021*PED► subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 20025,663,169*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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