APPLICATION
ANDA087794
TYPE
ANDA
ORIGINAL APPROVAL
1982-05-26
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
2025-03-07Labeling · Supplement 34 · standardAP
2024-11-21Labeling · Supplement 33 · standardAP
2024-10-31REMS · Supplement 32AP
2021-05-04Labeling · Supplement 31 · standardAP
2021-03-04Labeling · Supplement 30 · standardAP
2019-10-09Labeling · Supplement 29 · standardAP
2018-09-20Labeling · Supplement 28 · standardAP
2018-09-18REMS · Supplement 27AP
2017-03-07Labeling · Supplement 26 · standardAP
2016-12-16Labeling · Supplement 25 · standardAP
2016-12-16Labeling · Supplement 24 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 21AP
1994-12-23Manufacturing (CMC) · Supplement 20AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1991-08-07Manufacturing (CMC) · Supplement 16AP
1990-05-09Labeling · Supplement 15AP
1990-01-30Labeling · Supplement 14AP
1989-07-14Manufacturing (CMC) · Supplement 13AP
1989-05-15Labeling · Supplement 12AP
1988-03-31Manufacturing (CMC) · Supplement 11AP
1987-04-01Manufacturing (CMC) · Supplement 8AP
1986-02-04Manufacturing (CMC) · Supplement 3AP
1986-02-04Manufacturing (CMC) · Supplement 6AP
1986-02-04Manufacturing (CMC) · Supplement 4AP
1986-02-04Manufacturing (CMC) · Supplement 5AP
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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