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FDA NDA · NDA203794

NUCYNTA

Sponsor: COLLEGIUM PHARM INC

APPLICATION
NDA203794
TYPE
NDA
ORIGINAL APPROVAL
2012-10-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

NUCYNTA · ReferenceDiscontinued
TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 15 — Letter ↗AP
2025-12-22Labeling · Supplement 14 · standard — Label ↗AP
2024-10-31REMS · Supplement 12 — Letter ↗AP
2024-06-14Efficacy · Supplement 13 · priority — Letter ↗AP
2023-12-15Labeling · Supplement 11 · standard — Label ↗AP
2023-07-03Efficacy · Supplement 10 · priority — Letter ↗AP
2021-03-04Labeling · Supplement 9 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 8 · standard — Letter ↗AP
2018-09-18Labeling · Supplement 6 · standard — Label ↗AP
2018-09-18REMS · Supplement 5 — Label ↗AP
2016-12-16Labeling · Supplement 4 · standard — Label ↗AP
2014-11-17Labeling · Supplement 2 · standard — Label ↗AP
2014-11-17Labeling · Supplement 3 · standard — Label ↗AP
2014-01-16Manufacturing (CMC) · Supplement 1 · standardAP
2012-10-15Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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