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FDA ANDA · ANDA040144
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: VINTAGE PHARMS
APPLICATION
ANDA040144
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-22
LATEST ACTION
2002-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 2.5MG · TABLET · ORAL
Approval history
2002-11-18Labeling · Supplement 3AP
1997-04-25Manufacturing (CMC) · Supplement 1AP
1997-04-25Labeling · Supplement 2AP
1996-02-22OriginalAP
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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