APPLICATION
ANDA040910
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-16
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 6AP
2025-03-07Labeling · Supplement 5 · standardAP
2024-11-21Labeling · Supplement 4 · standardAP
2024-10-31REMS · Supplement 3AP
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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