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FDA ANDA · ANDA207709

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: AUROLIFE PHARMA LLC

APPLICATION
ANDA207709
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-13
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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 300MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 11AP
2025-12-22Labeling · Supplement 9 · standardAP
2024-10-31REMS · Supplement 8AP
2024-05-06Labeling · Supplement 7 · standardAP
2024-03-18Labeling · Supplement 6 · standardAP
2024-03-18Labeling · Supplement 4 · standardAP
2024-03-18Labeling · Supplement 5 · standardAP
2021-03-04Labeling · Supplement 3 · standardAP
2019-10-11Labeling · Supplement 2 · standardAP
2018-09-18REMS · Supplement 1AP
2018-09-13UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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