Bupropion Hydrochloride

Treats major depressive disorder (MDD). ANDA 205794, held by Sciegen Pharms. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 205794 (Bupropion Hydrochloride), held by Sciegen Pharms, was first approved by FDA on Mar 1, 2016, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 1, 2016
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 (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 hydrochloride extended-release tablets (SR) 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 8 submissions below

Date	Submission	Status	Documents
Mar 1, 2016	Original application	Approved	Letter

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 8 submissions, including labeling and manufacturing supplements


Apr 18, 2025	Supplement 37Labeling · Standard review	Approved	None posted
Apr 18, 2025	Supplement 40Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 28Labeling · Standard review	Approved	None posted
Dec 22, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Dec 22, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Nov 3, 2017	Supplement 3Labeling · Standard review	Approved	None posted
Apr 17, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Mar 1, 2016	Original application	Approved	Letter

Identifiers

Application: ANDA 205794
Drugs@FDA: Overview at FDA
Company: ScieGen 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