Orange Book product · Generic (ANDA)
CARBIDOPA AND LEVODOPA
CARBIDOPA; LEVODOPA
At a glance
Nov 28, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 28, 2022
3 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBIDOPA; LEVODOPA
Strength
10MG;100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 216537
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CARBIDOPA; LEVODOPA
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- 1992SINEMET CRBrand (NDA)
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- —SINEMETBrand (NDA)
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- 2025CARBIDOPA AND LEVODOPAGeneric (ANDA)
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- 2023CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 215999 · ZYDUS PHARMS
- 2022CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 216505 · RUBICON RESEARCH
- 2021CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 214091 · SCIEGEN PHARMS
- 2021CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 214092 · SCIEGEN PHARMS
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.

