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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
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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