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FDA NDA · NDA007337

PERCODAN

Sponsor: ENDO OPERATIONS

APPLICATION
NDA007337
TYPE
NDA
ORIGINAL APPROVAL
1950-04-12
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PERCODAN · ReferenceDiscontinued
ASPIRIN 325MG, OXYCODONE HYDROCHLORIDE 4.8355MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PERCODAN-DEMIDiscontinued
ASPIRIN 325MG, OXYCODONE HYDROCHLORIDE 2.25MG, OXYCODONE TEREPHTHALATE 0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PERCODANDiscontinued
ASPIRIN 325MG, OXYCODONE HYDROCHLORIDE 4.5MG, OXYCODONE TEREPHTHALATE 0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 59 — Letter ↗AP
2025-12-22Labeling · Supplement 58 · standard — Letter ↗AP
2024-11-21Labeling · Supplement 57 · standard — Label ↗AP
2024-10-31REMS · Supplement 56 — Letter ↗AP
2024-04-19Labeling · Supplement 55 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 54 · standard — Label ↗AP
2021-04-28Labeling · Supplement 53 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 52 · standard — Label ↗AP
2018-09-18REMS · Supplement 50 — Letter ↗AP
2018-09-18Labeling · Supplement 51 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 49 · standard — Letter ↗AP
2014-01-21Manufacturing (CMC) · Supplement 48 · standardAP
2013-09-24Manufacturing (CMC) · Supplement 47 · standardAP
2010-07-28Labeling · Supplement 46 · unknown — Letter ↗AP
2010-03-11Labeling · Supplement 45 · unknown — Letter ↗AP
2006-08-11Manufacturing (CMC) · Supplement 43 · standard — Label ↗AP
2004-06-10Labeling · Supplement 29 · standard — Letter ↗AP
2002-04-29Manufacturing (CMC) · Supplement 30 · standardAP
1995-03-17Manufacturing (CMC) · Supplement 27 · standardAP
1994-04-20Manufacturing (CMC) · Supplement 23 · standardAP
1994-04-19Manufacturing (CMC) · Supplement 25 · standardAP
1989-06-14Labeling · Supplement 24 — Review ↗AP
1987-12-17Manufacturing (CMC) · Supplement 22 · standardAP
1986-07-10Labeling · Supplement 20AP
1983-11-03Manufacturing (CMC) · Supplement 18 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 16 · standardAP
1980-01-24Manufacturing (CMC) · Supplement 14 · standardAP
1976-01-28Manufacturing (CMC) · Supplement 12 · standardAP
1975-07-28Labeling · Supplement 11AP
1975-03-31Manufacturing (CMC) · Supplement 9 · standardAP
1975-03-31Manufacturing (CMC) · Supplement 10 · standardAP
1950-04-12Type 4 - New Combination · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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