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FDA ANDA · ANDA076212

CARBIDOPA AND LEVODOPA

Sponsor: APOTEX

APPLICATION
ANDA076212
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-16
LATEST ACTION
2015-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

CARBIDOPA AND LEVODOPADiscontinued
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET, EXTENDED RELEASE · ORAL
CARBIDOPA AND LEVODOPADiscontinued
CARBIDOPA 50MG, LEVODOPA 200MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-11-17Labeling · Supplement 11 · standardAP
2010-12-30Labeling · Supplement 9AP
2004-06-16OriginalAP
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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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