Tramadol Hydrochloride

Manages pain severe enough to require daily, around-the-clock, long term opioid treatment. ANDA 91607, held by Sun Pharm. Tramadol Hydrochloride.

As of Nov 15, 2026, ANDA 91607 (Tramadol Hydrochloride), held by Sun Pharm, was first approved by FDA on Dec 30, 2011, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 30, 2011
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indications and Usage Section INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve tramadol hydrochloride extended-release tablets or use in patients for whom alternative treatment options [e.g.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 30, 2011	Original application	Approved	REMS Letter Review

Products

3 strengths and forms


Tramadol Hydrochloride100MG · tablet, extended release;oral	Tramadol Hydrochloride	Discontinued
Tramadol Hydrochloride200MG · tablet, extended release;oral	Tramadol Hydrochloride	Discontinued
Tramadol Hydrochloride300MG · tablet, extended release;oral	Tramadol Hydrochloride	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 37REMS	Approved	None posted
Dec 29, 2025	Supplement 36Labeling · Standard review	Approved	None posted
Dec 12, 2025	Supplement 32Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 33REMS	Approved	None posted
Dec 15, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Sep 10, 2021	Supplement 26Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 24Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 16Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 14REMS	Approved	None posted
Aug 29, 2017	Supplement 11Labeling · Standard review	Approved	None posted
Aug 29, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Aug 21, 2017	Supplement 10Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Dec 30, 2011	Original application	Approved	REMS Letter Review

Identifiers

Application: ANDA 91607
Drugs@FDA: Overview at FDA
Company: Sun 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