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FDA ANDA · ANDA202214

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: TRIS PHARMA INC

APPLICATION
ANDA202214
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-27
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
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 300MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 27AP
2025-12-22Labeling · Supplement 26 · standardAP
2025-12-22Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 21AP
2023-12-15Labeling · Supplement 18 · standardAP
2023-12-15Labeling · Supplement 17 · standardAP
2021-03-04Labeling · Supplement 14 · standardAP
2019-10-11Labeling · Supplement 10 · standardAP
2018-09-21Labeling · Supplement 9 · standardAP
2018-09-18REMS · Supplement 8AP
2018-09-12Labeling · Supplement 7 · standardAP
2018-09-12Labeling · Supplement 5 · standardAP
2016-12-16Labeling · Supplement 4 · standardAP
2016-12-16Labeling · Supplement 3 · standardAP
2016-03-15Manufacturing (CMC) · Supplement 2 · unknownAP
2013-10-18Labeling · Supplement 1 · standardAP
2013-03-27Original — REMS ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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