Bupropion Hydrochloride

Treats major depressive disorder (MDD). ANDA 79095, held by Actavis Labs Fl Inc. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 79095 (Bupropion Hydrochloride), held by Actavis Labs Fl Inc, was first approved by FDA on Mar 24, 2009, with 15 approved supplements and 0 published complete response letters.

First approved: Mar 24, 2009
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bupropion hydrochloride extended-release tablets, USP (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM ). The efficacy of bupropion 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. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Mar 24, 2009	Original application	Approved	None posted

Products

3 strengths and forms


Bupropion Hydrochloride100MG · tablet, extended release;oral	Bupropion Hydrochloride	Rx
Bupropion Hydrochloride150MG · tablet, extended release;oral	Bupropion Hydrochloride	Rx
Bupropion Hydrochloride200MG · tablet, extended release;oral	Bupropion Hydrochloride	Rx

All 16 submissions, including labeling and manufacturing supplements


Sep 2, 2026	Supplement 44Labeling · Standard review	Approved	None posted
Sep 2, 2026	Supplement 39Labeling · Standard review	Approved	None posted
Sep 2, 2026	Supplement 36Labeling · Standard review	Approved	None posted
Sep 2, 2026	Supplement 35Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 33Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Jun 14, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Jun 14, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Apr 23, 2012	Supplement 11Labeling	Approved	None posted
Aug 18, 2010	Supplement 9Labeling	Approved	None posted
Apr 27, 2010	Supplement 7REMS	Approved	None posted
Nov 16, 2009	Supplement 4Labeling	Approved	None posted
Mar 24, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 79095
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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