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FDA ANDA · ANDA201013
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: AUROLIFE PHARMA LLC
APPLICATION
ANDA201013
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-11
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 23AP
2025-12-31Labeling · Supplement 20 · standardAP
2025-12-31Labeling · Supplement 17 · standardAP
2024-10-31REMS · Supplement 18AP
2024-01-03Labeling · Supplement 16 · standardAP
2024-01-03Labeling · Supplement 15 · standardAP
2021-03-04Labeling · Supplement 14 · standardAP
2019-10-11Labeling · Supplement 13 · standardAP
2018-09-20Labeling · Supplement 12 · standardAP
2018-09-18REMS · Supplement 11AP
2017-06-01Labeling · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-16Labeling · Supplement 5 · standardAP
2016-12-15Labeling · Supplement 4 · standardAP
2013-10-25Labeling · Supplement 3 · standardAP
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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