Orange Book product · Generic (ANDA)
CARBIDOPA, LEVODOPA AND ENTACAPONE
CARBIDOPA; ENTACAPONE; LEVODOPA
At a glance
May 10, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 10, 2012
14 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Strength
25MG;200MG;100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 079085
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 090786 · WOCKHARDT LTD
- 2012CARBIDOPA, LEVODOPA AND ENTACAPONEGeneric (ANDA)
ANDA 090833 · WOCKHARDT LTD
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.
