FDA Orange Book · active-ingredient family
Acamprosate calcium
Acamprosate calcium: 1 brand, 6 generics; first approved Jul 29, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- CAMPRALRLDFOREST LABSNDA 0214312004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333MG TABLET, DELAYED RELEASE ORAL Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- ACAMPROSATE CALCIUMAPPCOANDA 2189842026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333MG TABLET, DELAYED RELEASE ORAL Rx AB - ACAMPROSATE CALCIUMBIONPHARMAANDA 2199042025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333MG TABLET, DELAYED RELEASE ORAL Rx AB - ACAMPROSATE CALCIUMZYDUS PHARMSANDA 2059952017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333MG TABLET, DELAYED RELEASE ORAL Rx AB - ACAMPROSATE CALCIUMMYLANANDA 2001422014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333MG TABLET, DELAYED RELEASE ORAL Rx AB - ACAMPROSATE CALCIUMBARR LABS DIV TEVAANDA 2001432013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333MG TABLET, DELAYED RELEASE ORAL Discontinued — - ACAMPROSATE CALCIUMRSGLENMARK PHARMS LTDANDA 2022292013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333MG TABLET, DELAYED RELEASE ORAL Rx AB
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
22 yr 4 mo ago
Most recent approval
5 mo ago
Approvals span 2004–2026 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Acamprosate calcium: 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.
