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FDA ANDA · ANDA040508

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MALLINCKRODT INC

APPLICATION
ANDA040508
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-29
LATEST ACTION
2003-08-29
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG/15ML, HYDROCODONE BITARTRATE 10MG/15ML · SOLUTION · ORAL

Approval history

2003-08-29OriginalAP
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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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