FDA Orange Book · active-ingredient family
Carbidopa
Carbidopa: 1 brand, 7 generics; first approved Mar 10, 2014; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- ATONNDA 017830—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB
Generic (ANDA) products (7)
Abbreviated applications
- CARBIDOPAREGCON HOLDINGSANDA 2179612023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - CARBIDOPAAUROBINDO PHARMAANDA 2110552019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - CARBIDOPAZYDUS PHARMSANDA 2099102018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - CARBIDOPANOVEL LABS INCANDA 2047632017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - CARBIDOPAEDENBRIDGE PHARMSANDA 2053042016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - CARBIDOPAALVOGENANDA 2042912016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - CARBIDOPAANI PHARMSANDA 2032612014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG 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
12 yr 8 mo ago
Most recent approval
2 yr 9 mo ago
Approvals span 2014–2023 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Carbidopa: 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.
