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FDA ANDA · ANDA211487
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: ASCENT PHARMS INC
APPLICATION
ANDA211487
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-07
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
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 2.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 17AP
2025-12-22Labeling · Supplement 15 · standardAP
2025-02-19Labeling · Supplement 11 · standardAP
2024-10-31REMS · Supplement 12AP
2023-12-15Labeling · Supplement 10 · standardAP
2023-12-15Labeling · Supplement 9 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2020-11-17Manufacturing (CMC) · Supplement 5 · unknownAP
2019-10-11Labeling · Supplement 1 · 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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