Tramadol Hydrochloride

Manages pain severe enough to require an opioid analgesic. ANDA 91498, held by Cspc Ouyi Pharm Co. Tramadol Hydrochloride.

As of Nov 15, 2026, ANDA 91498 (Tramadol Hydrochloride), held by Cspc Ouyi Pharm Co, was first approved by FDA on Mar 29, 2013, with 14 approved supplements and 0 published complete response letters.

First approved: Mar 29, 2013
Supplements approved: 14
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, and misuse with opioids, which can occur at any dosage or duration, reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Mar 29, 2013	Original application	Approved	REMS

Products

1 strengths and forms

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

All 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 17REMS	Approved	None posted
Dec 29, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Oct 21, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 15REMS	Approved	None posted
Dec 15, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Oct 18, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Jul 30, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Jul 30, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jul 30, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Jul 30, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Jul 30, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Jul 30, 2021	Supplement 11Manufacturing	Approved	None posted
Sep 18, 2018	Supplement 7REMS	Approved	None posted
Nov 5, 2014	Supplement 1Manufacturing	Approved	None posted
Mar 29, 2013	Original application	Approved	REMS

Identifiers

Application: ANDA 91498
Drugs@FDA: Overview at FDA
Company: CSPC Ouyi 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