Bupropion Hydrochloride

Treats major depressive disorder (MDD). ANDA 76143, held by Apotex. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 76143 (Bupropion Hydrochloride), held by Apotex, was first approved by FDA on Jan 17, 2006, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 17, 2006
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jan 17, 2006	Original application	Approved	None posted

Products

2 strengths and forms


Bupropion Hydrochloride75MG · tablet;oral	Bupropion Hydrochloride	Rx
Bupropion Hydrochloride100MG · tablet;oral	Bupropion Hydrochloride	Rx

All 23 submissions, including labeling and manufacturing supplements


Nov 5, 2025	Supplement 39Labeling · Standard review	Approved	None posted
Oct 6, 2025	Supplement 36Labeling · Standard review	Approved	None posted
Aug 22, 2024	Supplement 34Labeling · Standard review	Approved	None posted
May 7, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Oct 10, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 23Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 17Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Apr 16, 2012	Supplement 10Labeling	Approved	None posted
Jan 21, 2011	Supplement 9Labeling	Approved	None posted
Jul 8, 2010	Supplement 8REMS	Approved	None posted
Jan 22, 2010	Supplement 6Labeling	Approved	None posted
Jul 1, 2009	Supplement 4Labeling	Approved	None posted
Jan 15, 2008	Supplement 2Labeling	Approved	None posted
Oct 5, 2006	Supplement 1Labeling	Approved	None posted
Jan 17, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 76143
Drugs@FDA: Overview at FDA
Company: Apotex

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