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FDA ANDA · ANDA040757
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: AMNEAL PHARMS NY
APPLICATION
ANDA040757
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-25
LATEST ACTION
2008-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
Approval history
2008-03-20Manufacturing (CMC) · Supplement 1AP
2006-08-25OriginalAP
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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