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CARBIDOPA, LEVODOPA AND ENTACAPONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2026-02-05

Drug application

FDA Application #
ANDA218535
Application type
Abbreviated New Drug Application (Generic)
Brand name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Generic name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Active ingredients
CARBIDOPA; ENTACAPONE; LEVODOPA
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
ALEMBIC
Manufacturer
Alembic Pharmaceuticals Inc.
First approval
2026-02-05

Source

Authoritative
Drugs@FDA application overview
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