APPLICATION
ANDA078536
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-28
LATEST ACTION
2021-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 250MG · TABLET · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 10MG, LEVODOPA 100MG · TABLET · ORAL
CARBIDOPA AND LEVODOPAPrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET · ORAL
Approval history
2021-02-09Labeling · Supplement 23 · standardAP
2018-07-10Manufacturing (CMC) · Supplement 15AP
2015-02-06Labeling · Supplement 12 · standardAP
2013-04-05Labeling · Supplement 8 · standardAP
2010-10-04Labeling · Supplement 3AP
2008-10-28OriginalAP
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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