Tramadol Hydrochloride

Manages pain severe enough to require an opioid analgesic. ANDA 203494, held by Aurobindo Pharma Ltd. Tramadol Hydrochloride.

As of Nov 15, 2026, ANDA 203494 (Tramadol Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 31, 2014, with 15 approved supplements and 0 published complete response letters.

First approved: Mar 31, 2014
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including tramadol hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Mar 31, 2014	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tramadol Hydrochloride50MG · tablet;oral	Tramadol Hydrochloride	Rx

All 16 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 27REMS	Approved	None posted
Dec 29, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 24REMS	Approved	None posted
Dec 15, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Dec 4, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Dec 4, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Sep 23, 2020	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 23, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Sep 23, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Sep 23, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Sep 23, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Sep 23, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 8REMS	Approved	None posted
Oct 26, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Mar 31, 2014	Original application	Approved	REMS

Identifiers

Application: ANDA 203494
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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