Bupropion Hydrochloride

Treats major depressive disorder (MDD). ANDA 210081, held by Twi Pharms. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 210081 (Bupropion Hydrochloride), held by Twi Pharms, was first approved by FDA on Nov 3, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 3, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bupropion hydrochloride extended-release tablets (XL) are 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 4 submissions below

Date	Submission	Status	Documents
Nov 3, 2017	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 4 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Feb 7, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Feb 7, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Nov 3, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 210081
Drugs@FDA: Overview at FDA
Company: TWi Pharmaceuticals

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