APPLICATION
ANDA218535
TYPE
ANDA
ORIGINAL APPROVAL
2026-02-05
LATEST ACTION
2026-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARBIDOPA, LEVODOPA AND ENTACAPONEPrescription
CARBIDOPA 50MG, ENTACAPONE 200MG, LEVODOPA 200MG · TABLET · ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONEPrescription
CARBIDOPA 31.25MG, ENTACAPONE 200MG, LEVODOPA 125MG · TABLET · ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONEPrescription
CARBIDOPA 18.75MG, ENTACAPONE 200MG, LEVODOPA 75MG · TABLET · ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONEPrescription
CARBIDOPA 37.5MG, ENTACAPONE 200MG, LEVODOPA 150MG · TABLET · ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONEPrescription
CARBIDOPA 25MG, ENTACAPONE 200MG, LEVODOPA 100MG · TABLET · ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONEPrescription
CARBIDOPA 12.5MG, ENTACAPONE 200MG, LEVODOPA 50MG · TABLET · ORAL
Approval history
2026-02-05UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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