Tramadol Hydrochloride

ANDA 75960, held by Actavis Elizabeth. Tramadol Hydrochloride.

As of Nov 15, 2026, ANDA 75960 (Tramadol Hydrochloride), held by Actavis Elizabeth, was first approved by FDA on Jun 19, 2002, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 19, 2002
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 19, 2002	Original application	Approved	Letter Label

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Feb 6, 2008	Supplement 9Manufacturing	Approved	None posted
Aug 22, 2005	Supplement 5Labeling	Approved	None posted
Oct 17, 2002	Supplement 1Labeling	Approved	None posted
Jun 19, 2002	Original application	Approved	Letter Label

Identifiers

Application: ANDA 75960
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