APPLICATION
ANDA090324
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-28
LATEST ACTION
2021-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
CARBIDOPA AND LEVODOPADiscontinued
CARBIDOPA 25MG, LEVODOPA 250MG · TABLET · ORAL
CARBIDOPA AND LEVODOPADiscontinued
CARBIDOPA 10MG, LEVODOPA 100MG · TABLET · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET · ORAL
Approval history
2021-02-02Labeling · Supplement 8 · standardAP
2015-11-19Labeling · Supplement 5 · standardAP
2015-11-19Labeling · Supplement 4 · standardAP
2009-09-28OriginalAP
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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