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FDA ANDA · ANDA076642
HYDROCODONE BITARTRATE AND IBUPROFEN
Sponsor: AMNEAL PHARMS NY
APPLICATION
ANDA076642
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-18
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
HYDROCODONE BITARTRATE AND IBUPROFENPrescription
HYDROCODONE BITARTRATE 7.5MG, IBUPROFEN 200MG · TABLET · ORAL
REPREXAINPrescription
HYDROCODONE BITARTRATE 10MG, IBUPROFEN 200MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND IBUPROFENPrescription
HYDROCODONE BITARTRATE 5MG, IBUPROFEN 200MG · TABLET · ORAL
REPREXAINDiscontinued
HYDROCODONE BITARTRATE 2.5MG, IBUPROFEN 200MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 49AP
2025-12-22Labeling · Supplement 48 · standardAP
2024-11-21Labeling · Supplement 47 · standardAP
2024-10-31REMS · Supplement 45AP
2024-10-03Labeling · Supplement 44 · standardAP
2023-12-18Labeling · Supplement 41 · standardAP
2023-12-18Labeling · Supplement 42 · standardAP
2023-12-15Labeling · Supplement 35 · standardAP
2021-04-28Labeling · Supplement 32 · standardAP
2021-03-04Labeling · Supplement 30 · standardAP
2019-10-10Labeling · Supplement 28 · standardAP
2019-07-22Labeling · Supplement 27 · standardAP
2018-09-21Labeling · Supplement 24 · standardAP
2018-09-18REMS · Supplement 25AP
2018-08-15Labeling · Supplement 22 · standardAP
2018-08-15Labeling · Supplement 20 · standardAP
2018-08-15Labeling · Supplement 23 · standardAP
2008-03-20Manufacturing (CMC) · Supplement 11AP
2007-01-04Labeling · Supplement 10AP
2007-01-03Labeling · Supplement 9AP
2004-10-12Supplement · Supplement 3AP
2004-06-16Labeling · Supplement 2AP
2004-04-05Labeling · 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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