FDA ANDA · ANDA210341
CARBIDOPA AND LEVODOPA
Sponsor: ALEMBIC
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APPLICATION
ANDA210341
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-05
LATEST ACTION
2026-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 50MG, LEVODOPA 200MG · TABLET, EXTENDED RELEASE · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-01Labeling · Supplement 6 · standardAP
2019-06-05UNKNOWN · Original · standardAP
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