APPLICATION
ANDA201448
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-26
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG/5ML, OXYCODONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 7AP
2025-12-23Labeling · Supplement 6 · standardAP
2024-10-31REMS · Supplement 4AP
2024-09-19Labeling · Supplement 5 · standardAP
2024-09-19Labeling · Supplement 3 · standardAP
2023-12-15Labeling · Supplement 2 · standardAP
2023-12-15Labeling · Supplement 1 · 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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