Bupropion Hydrochloride

Treats major depressive disorder (MDD). ANDA 210015, held by Yichang Humanwell. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 210015 (Bupropion Hydrochloride), held by Yichang Humanwell, was first approved by FDA on Jun 14, 2018, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2018
Review: Standard
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Jun 14, 2018	Original application	Approved	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Mar 13, 2026	Supplement 31Labeling · Standard review	Approved	None posted
May 23, 2025	Supplement 28Labeling · Standard review	Approved	None posted
May 23, 2025	Supplement 25Labeling · Standard review	Approved	None posted
May 23, 2025	Supplement 22Labeling · Standard review	Approved	None posted
May 23, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Jan 3, 2022	Supplement 15Labeling · Standard review	Approved	None posted
Mar 16, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jun 14, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210015
Drugs@FDA: Overview at FDA
Company: Yichang Humanwell Pharmaceutical

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