FDA ANDA · ANDA214091
CARBIDOPA AND LEVODOPA
Sponsor: SCIEGEN PHARMS
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA214091
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-05
LATEST ACTION
2026-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET, EXTENDED RELEASE · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 50MG, LEVODOPA 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-01Labeling · Supplement 13 · standardAP
2021-10-05UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →