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FDA ANDA · ANDA203863
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: EPIC PHARMA LLC
APPLICATION
ANDA203863
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, 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
Approval history
2026-06-18REMS · Supplement 12AP
2025-12-22Labeling · Supplement 11 · standardAP
2024-10-31REMS · Supplement 10AP
2024-01-12Labeling · Supplement 7 · standardAP
2024-01-10Labeling · Supplement 6 · standardAP
2021-03-04Labeling · Supplement 5 · standardAP
2019-10-11Labeling · Supplement 3 · standardAP
2019-09-09Labeling · Supplement 2 · standardAP
2018-09-18REMS · Supplement 1AP
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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