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FDA NDA · NDA200533

TAPENTADOL

tapentadol hydrochloride

Sponsor: COLLEGIUM PHARM INC

APPLICATION
NDA200533
TYPE
NDA
ORIGINAL APPROVAL
2011-08-25
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

NUCYNTA ER · ReferencePrescription
TAPENTADOL HYDROCHLORIDE EQ 200MG BASE · TABLET, EXTENDED RELEASE · ORAL
NUCYNTA ER · ReferencePrescription
TAPENTADOL HYDROCHLORIDE EQ 100MG BASE · TABLET, EXTENDED RELEASE · ORAL
NUCYNTA ER · ReferencePrescription
TAPENTADOL HYDROCHLORIDE EQ 250MG BASE · TABLET, EXTENDED RELEASE · ORAL
NUCYNTA ER · ReferencePrescription
TAPENTADOL HYDROCHLORIDE EQ 150MG BASE · TABLET, EXTENDED RELEASE · ORAL
NUCYNTA ER · ReferencePrescription
TAPENTADOL HYDROCHLORIDE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 32 — Letter ↗AP
2025-12-22Labeling · Supplement 31 · standard — Label ↗AP
2024-10-31REMS · Supplement 28 — Letter ↗AP
2024-06-14Efficacy · Supplement 29 · priority — Letter ↗AP
2023-12-15Labeling · Supplement 27 · standard — Label ↗AP
2021-03-04Labeling · Supplement 23 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 20 · standard — Letter ↗AP
2018-09-18Labeling · Supplement 19 · standard — Label ↗AP
2018-09-18REMS · Supplement 18 — Label ↗AP
2017-05-26REMS · Supplement 16 — Letter ↗AP
2016-12-16Labeling · Supplement 14 · standard — Label ↗AP
2016-09-30REMS · Supplement 15 — Letter ↗AP
2016-04-20REMS · Supplement 13 — Letter ↗AP
2015-06-26REMS · Supplement 12 — Letter ↗AP
2014-08-19REMS · Supplement 11 — Letter ↗AP
2014-04-16Labeling · Supplement 10 · 901 required — Label ↗AP
2014-01-16Manufacturing (CMC) · Supplement 7 · standardAP
2013-04-15REMS · Supplement 4 — Letter ↗AP
2012-08-28Efficacy · Supplement 1 · standard — Label ↗AP
2012-07-09REMS · Supplement 2 — Label ↗AP
2011-08-25Type 3 - New Dosage Form · Original · standard — Review ↗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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