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Last Updated: May 25, 2024

Details for New Drug Application (NDA): 020972


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NDA 020972 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 are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the efavirenz profile page.
Summary for 020972
Tradename:SUSTIVA
Applicant:Bristol Myers Squibb
Ingredient:efavirenz
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Sep 17, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 17, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG
Approval Date:Sep 17, 1998TE:RLD:Yes

Expired US Patents for NDA 020972

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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