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FDA ANDA · ANDA204575
HYDROCODONE BITARTRATE AND IBUPROFEN
Sponsor: AUROLIFE PHARMA LLC
APPLICATION
ANDA204575
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-02
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND IBUPROFENPrescription
HYDROCODONE BITARTRATE 7.5MG, IBUPROFEN 200MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 14AP
2025-12-22Labeling · Supplement 13 · standardAP
2024-11-21Labeling · Supplement 12 · standardAP
2024-10-31REMS · Supplement 11AP
2023-12-15Labeling · Supplement 9 · standardAP
2023-12-15Labeling · Supplement 10 · standardAP
2021-04-28Labeling · Supplement 7 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2019-10-11Labeling · Supplement 5 · standardAP
2019-07-22Labeling · Supplement 4 · standardAP
2018-09-20Labeling · Supplement 3 · standardAP
2018-09-18REMS · Supplement 2AP
2018-08-15Labeling · 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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