Bupropion Hydrochloride

ANDA 90693, held by Lupin. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 90693 (Bupropion Hydrochloride), held by Lupin, was first approved by FDA on Apr 6, 2017, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2017
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bupropion hydrochloride extended-release tablet (XL) is 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
Apr 6, 2017	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


Jul 3, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Jun 24, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Jun 24, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Feb 11, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Jul 10, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jul 10, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jan 24, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Apr 6, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 90693
Drugs@FDA: Overview at FDA
Company: Lupin

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