← FDA DRUG APPROVALS

FDA NDA · NDA208090

XTAMPZA ER

oxycodone

Sponsor: COLLEGIUM PHARM INC

APPLICATION
NDA208090
TYPE
NDA
ORIGINAL APPROVAL
2016-04-26
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

XTAMPZA ER · ReferencePrescription
OXYCODONE 18MG · CAPSULE, EXTENDED RELEASE · ORAL
XTAMPZA ER · ReferencePrescription
OXYCODONE 9MG · CAPSULE, EXTENDED RELEASE · ORAL
XTAMPZA ER · ReferencePrescription
OXYCODONE 27MG · CAPSULE, EXTENDED RELEASE · ORAL
XTAMPZA ER · ReferencePrescription
OXYCODONE 13.5MG · CAPSULE, EXTENDED RELEASE · ORAL
XTAMPZA ER · ReferencePrescription
OXYCODONE 36MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 25 — Letter ↗AP
2025-12-22Labeling · Supplement 24 · standard — Letter ↗AP
2024-10-31REMS · Supplement 23 — Letter ↗AP
2023-12-15Labeling · Supplement 21 · standard — Label ↗AP
2021-03-04Labeling · Supplement 15 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 12 · standard — Letter ↗AP
2018-10-26Labeling · Supplement 9 · standard — Letter ↗AP
2018-09-18REMS · Supplement 8 — Label ↗AP
2018-09-18Labeling · Supplement 10 · standard — Label ↗AP
2017-11-06Efficacy · Supplement 4 · standard — Label ↗AP
2017-05-26REMS · Supplement 6 — Letter ↗AP
2016-12-16Labeling · Supplement 3 · standard — Label ↗AP
2016-09-30REMS · Supplement 2 — Letter ↗AP
2016-04-26Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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