Tramadol Hydrochloride

ANDA 91609, held by Actavis Elizabeth. Tramadol Hydrochloride.

As of Nov 15, 2026, ANDA 91609 (Tramadol Hydrochloride), held by Actavis Elizabeth, was first approved by FDA on Jun 27, 2012, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2012
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 27, 2012	Original application	Approved	REMS

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 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 17REMS	Approved	None posted
Dec 23, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Dec 12, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 14REMS	Approved	None posted
Dec 15, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Sep 10, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 7REMS	Approved	None posted
Aug 29, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Aug 21, 2017	Supplement 5Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Jun 27, 2012	Original application	Approved	REMS

Identifiers

Application: ANDA 91609
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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