Orange Book product · Brand (NDA)
SINEMET CR
CARBIDOPA; LEVODOPA
At a glance
Dec 24, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 1992
34 yr ago
Today
Pharmaceutical detail
Active ingredient
CARBIDOPA; LEVODOPA
Strength
25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 019856
Product number
002
Marketing status
DISCN
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
- —SINEMETBrand (NDA)
NDA 017555 · ORGANON
- 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.
