APPLICATION
ANDA090084
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-22
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE AND ASPIRINDiscontinued
ASPIRIN 325MG, OXYCODONE HYDROCHLORIDE 4.8355MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 15AP
2025-02-28Labeling · Supplement 14 · standardAP
2024-11-21Labeling · Supplement 13 · standardAP
2024-10-31REMS · Supplement 12AP
2021-05-03Labeling · Supplement 11 · standardAP
2021-03-04Labeling · Supplement 10 · standardAP
2019-10-08Labeling · Supplement 8 · standardAP
2018-09-21Labeling · Supplement 7 · standardAP
2018-09-18REMS · Supplement 5AP
2018-09-11Labeling · Supplement 6 · 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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