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FDA ANDA · ANDA040442

CARBINOXAMINE MALEATE

Sponsor: GENUS

APPLICATION
ANDA040442
TYPE
ANDA
ORIGINAL APPROVAL
2003-03-19
LATEST ACTION
2010-08-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CARBINOXAMINE MALEATEDiscontinued
CARBINOXAMINE MALEATE 4MG · TABLET · ORAL

Approval history

2010-08-25Labeling · Supplement 6AP
2007-04-12Labeling · Supplement 4AP
2006-06-07Labeling · Supplement 3AP
2003-03-19OriginalAP
VIEW ON DRUGS@FDA ↗

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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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