← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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