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FDA ANDA · ANDA216505
CARBIDOPA-LEVODOPA
carbidopa and levodopa
Sponsor: RUBICON RESEARCH
APPLICATION
ANDA216505
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-21
LATEST ACTION
2026-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 250MG · TABLET · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 10MG, LEVODOPA 100MG · TABLET · ORAL
Approval history
2026-06-24Labeling · Supplement 14 · standardAP
2022-09-21UNKNOWN · 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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