Nucynta

Manages acute pain severe enough to require an opioid analgesic. NDA 22304, held by Collegium Pharm Inc. Tapentadol Hydrochloride.

As of Nov 13, 2026, NDA 22304 (Nucynta), held by Collegium Pharm Inc, was first approved by FDA on Nov 20, 2008, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 20, 2008
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Jun 14, 2024	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Jul 3, 2023	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 20, 2008	Original applicationNew molecular entity · Standard review	Approved	REMS Label Review Summary Review

Products

3 strengths and forms


NucyntaEQ 50MG BASE · tablet;oral	Tapentadol Hydrochloride	RxReference drug
NucyntaEQ 75MG BASE · tablet;oral	Tapentadol Hydrochloride	RxReference drug
NucyntaEQ 100MG BASE · tablet;oral	Tapentadol Hydrochloride	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 30REMS	Approved	Letter
Dec 22, 2025	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 31, 2024	Supplement 27REMS	Approved	Letter
Jun 14, 2024	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Dec 15, 2023	Supplement 26Labeling · Standard review	Approved	Letter Label
Jul 3, 2023	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 4, 2021	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 22Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 21Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 19REMS	Approved	Letter Label
Dec 16, 2016	Supplement 16Labeling · Standard review	Approved	Letter Label
Jan 16, 2014	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 31, 2013	Supplement 15Labeling · Standard review	Approved	Letter Label
Oct 31, 2013	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 11, 2013	Supplement 12Labeling · Standard review	Approved	Letter Label
Jul 11, 2013	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 11, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 11, 2013	Supplement 8Labeling · Standard review	Approved	Label Letter
Jul 11, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 1, 2010	Supplement 4Labeling	Approved	Letter Label
Nov 1, 2010	Supplement 3Labeling	Approved	Letter Label
Nov 9, 2009	Supplement 1Labeling · Standard review	Approved	Letter Label
Nov 20, 2008	Original applicationNew molecular entity · Standard review	Approved	REMS Label Review Summary Review

Identifiers

Application: NDA 22304
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