FDA Orange Book · active-ingredient family
Albendazole
Albendazole: 1 brand, 9 generics; first approved Jun 11, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- ALBENZARLDIMPAX LABS INCNDA 0206661996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- ALBENDAZOLEALEMBICANDA 2156522024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ALBENDAZOLERSDR REDDYSANDA 2110342021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ALBENDAZOLEMSNANDA 2134352021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ALBENDAZOLECHARTWELL RXANDA 2116362020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - ALBENDAZOLEACTAVIS ELIZABETHANDA 2080942019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ALBENDAZOLEEDENBRIDGE PHARMSANDA 2111172019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ALBENDAZOLEZYDUS PHARMSANDA 2089792018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ALBENDAZOLESTRIDES PHARMAANDA 2100112018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - ALBENDAZOLECIPLA LTDANDA 2104342018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
30 yr 8 mo ago
Most recent approval
2 yr ago
Approvals span 1996–2024 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Albendazole: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
