Orange Book product · Generic (ANDA)
CARBIDOPA, LEVODOPA AND ENTACAPONE
CARBIDOPA; ENTACAPONE; LEVODOPA
At a glance
Nov 20, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2012
13 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Strength
12.5MG;200MG;50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 090786
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CARBIDOPA; ENTACAPONE; LEVODOPA
- 2003STALEVO 100Brand (NDA)
NDA 021485 · ORION PHARMA
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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 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.
