← FDA DRUG APPROVALS

FDA ANDA · ANDA213212

CARBIDOPA, LEVODOPA AND ENTACAPONE

Sponsor: RISING

APPLICATION
ANDA213212
TYPE
ANDA
ORIGINAL APPROVAL
2022-01-25
LATEST ACTION
2022-01-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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
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

Approval history

2022-01-25UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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