Orange Book product · Brand (NDA)
SINEMET
CARBIDOPA; LEVODOPA
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CARBIDOPA; LEVODOPA
Strength
10MG;100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 017555
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024CREXONTBrand (NDA)
NDA 217186 · IMPAX
- 2021DHIVYBrand (NDA)
NDA 214869 · AVION PHARMS
- 2015DUOPABrand (NDA)
NDA 203952 · ABBVIE
- 2015RYTARYBrand (NDA)
NDA 203312 · IMPAX
- 1992SINEMET CRBrand (NDA)
NDA 019856 · ORGANON LLC
- 2025CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 218939 · ASCENT PHARMS INC
- 2024CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 217482 · RUBICON RESEARCH
- 2023CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 215999 · ZYDUS PHARMS
- 2022CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 216537 · AUROBINDO PHARMA LTD
- 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.
