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FDA Orange Book · active-ingredient family

Abacavir sulfate; lamivudine; zidovudine

Abacavir sulfate; lamivudine; zidovudine: 1 brand, 1 generic; first approved Nov 14, 2000; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 1 ANDA application approved.

Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
2
Originator applications

Brand (NDA) products

NDA 0212052000
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
Abbreviated applications

Generic (ANDA) products (1)

Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 300MG BASE;150MG;300MGTABLETORALDiscontinued
Orange Book patent file

Listed patents

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval
Nov 14, 2000
26 yr ago
Most recent approval
Dec 05, 2013
12 yr 9 mo ago

Approvals span 2000–2013 across 2 FDA applications.

Brand (NDA) 150%
Generic (ANDA) 150%

Abacavir sulfate; lamivudine; zidovudine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Agent CTA Background

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