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FDA Orange Book · active-ingredient family

Carbidopa

Carbidopa is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LODOSYN · NDA 017830

1

Brand (NDA)

7

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
LODOSYNRLDATONNDA 017830ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (7)

ProductApplicantApplicationTEApproved
CARBIDOPAREGCON HOLDINGSANDA 217961ABDec 11, 2023
CARBIDOPAAUROBINDO PHARMAANDA 211055ABOct 21, 2019
CARBIDOPAZYDUS PHARMSANDA 209910ABMay 07, 2018
CARBIDOPANOVEL LABS INCANDA 204763ABOct 20, 2017
CARBIDOPAEDENBRIDGE PHARMSANDA 205304ABFeb 17, 2016
CARBIDOPAALVOGENANDA 204291Jan 08, 2016
CARBIDOPAANI PHARMSANDA 203261Mar 10, 2014

Listed patents

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.

Carbidopa — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.