Ultram

NDA 20281, held by Janssen Pharms. Tramadol Hydrochloride.

As of Nov 13, 2026, NDA 20281 (Ultram), held by Janssen Pharms, was first approved by FDA on Mar 3, 1995, with 35 approved supplements and 0 published complete response letters.

First approved: Mar 3, 1995
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Dec 23, 1999	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 21, 1998	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 3, 1995	Original applicationNew molecular entity · Standard review	Approved	REMS Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ultram100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Tramadol Hydrochloride	DiscontinuedReference drug
Ultram50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Tramadol Hydrochloride	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 13, 2023	Supplement 40Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 10, 2021	Supplement 49Labeling · Standard review	Approved	Letter Label
Mar 4, 2021	Supplement 48Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 45Labeling · Standard review	Approved	Label Letter
Apr 8, 2019	Supplement 41Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 43Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 42REMS	Approved	Label Letter
Aug 29, 2017	Supplement 39Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 38Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 36Labeling · Standard review	Approved	Label Letter
Sep 9, 2009	Supplement 33Labeling · Standard review	Approved	Letter Label
Sep 9, 2009	Supplement 32Labeling · Standard review	Approved	Letter Label
Apr 16, 2004	Supplement 30Labeling · Standard review	Approved	Label Letter
Aug 15, 2001	Supplement 29Labeling · Standard review	Approved	Label
Feb 13, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 2, 2000	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 10, 2000	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 21, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 8, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 23, 1999	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 20, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 15Labeling · Standard review	Approved	Letter Review
Aug 21, 1998	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Review
Nov 20, 1997	Supplement 13Labeling · Standard review	Approved	None posted
Nov 20, 1997	Supplement 12Labeling · Standard review	Approved	None posted
Nov 27, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 30, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 20, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Mar 20, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Mar 20, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Mar 20, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Mar 20, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Dec 22, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 22, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 20, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 3, 1995	Original applicationNew molecular entity · Standard review	Approved	REMS Review

Identifiers

Application: NDA 20281
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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