Nucynta

NDA 203794, held by Collegium Pharm Inc. Tapentadol Hydrochloride.

As of Nov 14, 2026, NDA 203794 (Nucynta), held by Collegium Pharm Inc, was first approved by FDA on Oct 15, 2012, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2012
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Jun 14, 2024	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Jul 3, 2023	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 15, 2012	Original applicationNew dosage form · Standard review	Approved	REMS Summary Review Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
NucyntaEQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Tapentadol Hydrochloride	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 15REMS	Approved	Letter
Dec 22, 2025	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 31, 2024	Supplement 12REMS	Approved	Letter
Jun 14, 2024	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Dec 15, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
Jul 3, 2023	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 4, 2021	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 8Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 5REMS	Approved	Letter Label Review
Sep 18, 2018	Supplement 6Labeling · Standard review	Approved	Letter Label Review
Dec 16, 2016	Supplement 4Labeling · Standard review	Approved	Letter Label
Nov 17, 2014	Supplement 2Labeling · Standard review	Approved	Label Letter
Nov 17, 2014	Supplement 3Labeling · Standard review	Approved	Label Letter
Jan 16, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 15, 2012	Original applicationNew dosage form · Standard review	Approved	REMS Summary Review Review Letter

Identifiers

Application: NDA 203794
Drugs@FDA: Overview at FDA
Company: Collegium Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters