APPLICATION
ANDA040255
TYPE
ANDA
ORIGINAL APPROVAL
1998-02-27
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE AND ASPIRINDiscontinued
ASPIRIN 325MG, OXYCODONE HYDROCHLORIDE 4.5MG, OXYCODONE TEREPHTHALATE 0.38MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 35AP
2025-03-14Labeling · Supplement 34 · standardAP
2024-11-21Labeling · Supplement 33 · standardAP
2024-10-31REMS · Supplement 32AP
2021-04-28Labeling · Supplement 31 · standardAP
2021-03-04Labeling · Supplement 30 · standardAP
2019-10-08Labeling · Supplement 29 · standardAP
2018-09-21Labeling · Supplement 28 · standardAP
2018-09-18REMS · Supplement 27AP
2017-06-29Labeling · Supplement 26 · standardAP
2016-12-16Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 25 · standardAP
2004-12-13Labeling · Supplement 6AP
2000-03-21Manufacturing (CMC) · Supplement 2AP
1998-08-21Manufacturing (CMC) · 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.
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.