APPLICATION
ANDA079085
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-10
LATEST ACTION
2014-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARBIDOPA, LEVODOPA AND ENTACAPONEDiscontinued
CARBIDOPA 25MG, ENTACAPONE 200MG, LEVODOPA 100MG · TABLET · ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONEDiscontinued
CARBIDOPA 37.5MG, ENTACAPONE 200MG, LEVODOPA 150MG · TABLET · ORAL
Approval history
2014-12-13Labeling · Supplement 1 · standardAP
2012-05-10OriginalAP
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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