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FDA ANDA · ANDA040201
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: MALLINCKRODT
APPLICATION
ANDA040201
TYPE
ANDA
ORIGINAL APPROVAL
1998-02-27
LATEST ACTION
2011-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2011-06-24Labeling · Supplement 29AP
2002-11-13Labeling · Supplement 11AP
2002-09-27Manufacturing (CMC) · Supplement 10AP
2002-08-05Labeling · Supplement 9AP
2002-08-05Manufacturing (CMC) · Supplement 8AP
2002-04-11Manufacturing (CMC) · Supplement 7AP
2000-04-25Manufacturing (CMC) · Supplement 5AP
2000-04-25Manufacturing (CMC) · Supplement 3AP
2000-04-25Manufacturing (CMC) · Supplement 1AP
2000-04-25Labeling · Supplement 6AP
2000-04-25Manufacturing (CMC) · Supplement 4AP
2000-04-25Manufacturing (CMC) · Supplement 2AP
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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