FDA Orange Book · active-ingredient family
Carvedilol
Carvedilol: 1 brand, 17 generics; first approved Sep 14, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 17 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
17
Listed patents
0
Presentations
72
Brand (NDA) products
Originator applications
- COREGRLDWAYLIS THERAPNDA 02029719974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 3.125MG TABLET ORAL Rx AB
Generic (ANDA) products (17)
Abbreviated applications
- CARVEDILOLMLVANDA 07878620094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLPLIVA HRVATSKA DOOANDA 07824020074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Discontinued — 6.25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - CARVEDILOLHIKMAANDA 07788720074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Discontinued — 6.25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - CARVEDILOLALLIEDANDA 07731620074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Discontinued — 6.25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - CARVEDILOLAUROBINDO PHARMAANDA 07833220074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLCHARTWELL MOLECULARANDA 07747420074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLGLENMARK PHARMS LTDANDA 07825120074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLLUPINANDA 07821720074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Discontinued — 6.25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - CARVEDILOLREGCON HOLDINGSANDA 07838420074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLRISINGANDA 07664920074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLRUBICON RESEARCHANDA 07816520074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLSANDOZANDA 07822720074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLSUN PHARM INDS INCANDA 07734620074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6.25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 3.125MG TABLET ORAL Discontinued — - CARVEDILOLSUN PHARM INDS LTDANDA 07698920074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Discontinued — 6.25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - CARVEDILOLTAROANDA 07778020074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Discontinued — 6.25MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — - CARVEDILOLTEVAANDA 07637320074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.125MG TABLET ORAL Rx AB 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - CARVEDILOLZYDUS PHARMS USA INCANDA 07761420074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6.25MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 3.125MG TABLET 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
31 yr 5 mo ago
Most recent approval
16 yr 11 mo ago
Approvals span 1995–2009 across 18 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1794%
Carvedilol: 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.
