Nucynta Er

For a daily opioid analgesic. NDA 200533, held by Collegium Pharm Inc. Tapentadol Hydrochloride.

As of Nov 14, 2026, NDA 200533 (Nucynta Er), held by Collegium Pharm Inc, was first approved by FDA on Aug 25, 2011, with 20 approved supplements and 0 published complete response letters.

First approved: Aug 25, 2011
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tapentadol extended-release tablets are indicated for the management of: Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Jun 14, 2024	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Aug 28, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 25, 2011	Original applicationNew dosage form · Standard review	Approved	Review Other Letter Label

Products

5 strengths and forms


Nucynta ErEQ 50MG BASE · tablet, extended release;oral	Tapentadol Hydrochloride	RxReference drug
Nucynta ErEQ 100MG BASE · tablet, extended release;oral	Tapentadol Hydrochloride	RxReference drug
Nucynta ErEQ 150MG BASE · tablet, extended release;oral	Tapentadol Hydrochloride	RxReference drug
Nucynta ErEQ 200MG BASE · tablet, extended release;oral	Tapentadol Hydrochloride	RxReference drug
Nucynta ErEQ 250MG BASE · tablet, extended release;oral	Tapentadol Hydrochloride	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 32REMS	Approved	Letter
Dec 22, 2025	Supplement 31Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 28REMS	Approved	Letter Letter
Jun 14, 2024	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Dec 15, 2023	Supplement 27Labeling · Standard review	Approved	Letter Label
Mar 4, 2021	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 19Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 18REMS	Approved	Letter Label
May 26, 2017	Supplement 16REMS	Approved	Letter
Dec 16, 2016	Supplement 14Labeling · Standard review	Approved	Letter Label
Sep 30, 2016	Supplement 15REMS	Approved	Letter
Apr 20, 2016	Supplement 13REMS	Approved	Letter
Jun 26, 2015	Supplement 12REMS	Approved	Letter
Aug 19, 2014	Supplement 11REMS	Approved	Letter
Apr 16, 2014	Supplement 10Labeling	Approved	Letter Label
Jan 16, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 15, 2013	Supplement 4REMS	Approved	Letter
Aug 28, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 9, 2012	Supplement 2REMS	Approved	Label Letter
Aug 25, 2011	Original applicationNew dosage form · Standard review	Approved	Review Other Letter Label

Identifiers

Application: NDA 200533
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