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FDA ANDA · ANDA077828

CARBIDOPA AND LEVODOPA

Sponsor: SUN PHARM INDS

APPLICATION
ANDA077828
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-23
LATEST ACTION
2015-09-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

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

Approval history

2015-09-24Labeling · Supplement 8 · standardAP
2013-04-03Labeling · Supplement 4 · standardAP
2007-08-23OriginalAP
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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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