FDA Orange Book · active-ingredient family
Disulfiram
Disulfiram: 1 brand, 13 generics; first approved Aug 05, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
0
Presentations
19
Brand (NDA) products
Originator applications
- ANTABUSERLDTEVA WOMENSNDA 007883—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- DISULFIRAMNATCO PHARMA USAANDA 20391620152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - DISULFIRAMHIKMAANDA 20265220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - DISULFIRAMALVOGENANDA 0916812013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - DISULFIRAMCHARTWELL MOLECULESANDA 09156320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - DISULFIRAMSIGMAPHARM LABS LLCANDA 09161920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - DISULFIRAMSTRIDES PHARMA INTLANDA 0887921984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - DISULFIRAMSTRIDES PHARMA INTLANDA 0887931984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - ANTABUSERLDODYSSEY PHARMSANDA 0884821983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - ANTABUSERLDODYSSEY PHARMSANDA 0884831983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - DISULFIRAMWATSON LABSANDA 0879731983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - DISULFIRAMWATSON LABSANDA 0879741983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - DISULFIRAMWATSON LABSANDA 086889—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - DISULFIRAMWATSON LABS TEVAANDA 086890—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG 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
43 yr 8 mo ago
Most recent approval
11 yr 7 mo ago
Approvals span 1983–2015 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Disulfiram: 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.
