Bupropion Hydrochloride

Treats major depressive disorder (MDD). ANDA 206556, held by Invagen Pharms. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 206556 (Bupropion Hydrochloride), held by Invagen Pharms, was first approved by FDA on Aug 26, 2016, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 26, 2016
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bupropion hydrochloride extended-release tablet, (XL) is an aminoketone antidepressant, indicated for

treatment of major depressive disorder (MDD)
prevention of seasonal affective disorder (SAD) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 26, 2016	Original application	Approved	None posted

Products

2 strengths and forms


Bupropion Hydrochloride150MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued
Bupropion Hydrochloride300MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Aug 19, 2026	Supplement 19Labeling · Standard review	Approved	None posted
Feb 1, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Feb 1, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Jun 30, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jun 12, 2017	Supplement 3Labeling · Standard review	Approved	None posted
Aug 26, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206556
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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