Orange Book product · Generic (ANDA)
CARBIDOPA, LEVODOPA AND ENTACAPONE
CARBIDOPA; ENTACAPONE; LEVODOPA
At a glance
Jan 25, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 25, 2022
4 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Strength
12.5MG;200MG;50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213212
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CARBIDOPA; ENTACAPONE; LEVODOPA
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ANDA 218535 · ALEMBIC
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ANDA 214495 · MACLEODS PHARMS LTD
- 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.
