← FDA DRUG APPROVALS

FDA ANDA · ANDA076699

PARCOPA

Sponsor: UCB INC

APPLICATION
ANDA076699
TYPE
ANDA
ORIGINAL APPROVAL
2004-08-27
LATEST ACTION
2010-12-30
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

PARCOPADiscontinued
CARBIDOPA 25MG, LEVODOPA 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
PARCOPADiscontinued
CARBIDOPA 10MG, LEVODOPA 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
PARCOPADiscontinued
CARBIDOPA 25MG, LEVODOPA 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2010-12-30Labeling · Supplement 4AP
2004-08-27Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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