Orange Book product · Brand (NDA)
STALEVO 100
CARBIDOPA; ENTACAPONE; LEVODOPA
At a glance
Jun 11, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 11, 2003
23 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Strength
25MG;200MG;100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021485
Product number
002
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.
- 2026CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 218535 · ALEMBIC
- 2025CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 214495 · MACLEODS PHARMS LTD
- 2022CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 213212 · RISING
- 2020CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 203424 · PHARMOBEDIENT
- 2012CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 090786 · WOCKHARDT LTD
- 2012CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 090833 · WOCKHARDT LTD
- 2012CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 079085 · SUN PHARM
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.
