APPLICATION
ANDA040260
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-17
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 23AP
2025-03-14Labeling · Supplement 22 · standardAP
2024-11-21Labeling · Supplement 21 · standardAP
2024-10-31REMS · Supplement 20AP
2021-05-04Labeling · Supplement 19 · standardAP
2021-03-04Labeling · Supplement 18 · standardAP
2019-10-09Labeling · Supplement 17 · standardAP
2018-09-20Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 15AP
2017-03-07Labeling · Supplement 14 · standardAP
2016-12-16Labeling · Supplement 13 · standardAP
2016-12-16Labeling · Supplement 12 · standardAP
2002-07-24Manufacturing (CMC) · Supplement 9AP
2002-02-08Manufacturing (CMC) · Supplement 8AP
2001-11-02Manufacturing (CMC) · Supplement 6AP
2001-09-24Manufacturing (CMC) · Supplement 7AP
2000-12-18Manufacturing (CMC) · Supplement 5AP
2000-12-18Manufacturing (CMC) · Supplement 3AP
2000-12-18Manufacturing (CMC) · Supplement 4AP
2000-12-18Manufacturing (CMC) · 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.
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