Tramadol Hydrochloride

ANDA 202390, held by Accord Hlthcare. Tramadol Hydrochloride.

As of Nov 15, 2026, ANDA 202390 (Tramadol Hydrochloride), held by Accord Hlthcare, was first approved by FDA on May 16, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: May 16, 2013
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 16, 2013	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Oct 26, 2015	Supplement 1Labeling · Standard review	Approved	None posted
May 16, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202390
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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