Ultram Er

NDA 21692, held by Valeant Pharms. Tramadol Hydrochloride.

As of Nov 14, 2026, NDA 21692 (Ultram Er), held by Valeant Pharms, was first approved by FDA on Sep 8, 2005, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 8, 2005
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Sep 8, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Ultram Er100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Tramadol Hydrochloride	DiscontinuedReference drug
Ultram Er200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Tramadol Hydrochloride	DiscontinuedReference drug
Ultram Er300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Tramadol Hydrochloride	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Aug 29, 2017	Supplement 15Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 16, 2016	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 27, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 17, 2009	Supplement 9Manufacturing	Approved	Letter
Feb 20, 2008	Supplement 5Labeling · Standard review	Approved	Label Letter
Feb 20, 2008	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 3, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Jun 5, 2006	Supplement 1Labeling · Standard review	Approved	Letter
Sep 8, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21692
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals

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