Details for New Drug Application (NDA): 021360
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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 |
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DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | ||||
Approval Date: | Feb 1, 2002 | TE: | RLD: | 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 | 021360-002 | Feb 1, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-001 | Feb 1, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-002 | Feb 1, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-002 | Feb 1, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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