← FDA DRUG APPROVALS
FDA ANDA · ANDA078316
OXYCODONE HYDROCHLORIDE AND IBUPROFEN
Sponsor: BARR LABS INC
APPLICATION
ANDA078316
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-29
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE HYDROCHLORIDE AND IBUPROFENDiscontinued
IBUPROFEN 400MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 22AP
2025-12-22Labeling · Supplement 21 · standardAP
2024-11-21Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 19AP
2024-03-11Labeling · Supplement 17 · standardAP
2024-03-11Labeling · Supplement 18 · standardAP
2023-12-15Labeling · Supplement 15 · standardAP
2023-12-15Labeling · Supplement 16 · standardAP
2021-04-28Labeling · Supplement 13 · standardAP
2021-03-04Labeling · Supplement 12 · standardAP
2019-10-07Labeling · Supplement 11 · standardAP
2019-07-22Labeling · Supplement 10 · standardAP
2019-02-28Labeling · Supplement 7 · standardAP
2018-09-21Labeling · Supplement 9 · standardAP
2018-09-18REMS · Supplement 8AP
2016-12-16Labeling · Supplement 5 · standardAP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-16Labeling · Supplement 4 · standardAP
2015-02-18Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.