Bupropion Hydrochloride

ANDA 211020, held by Graviti Pharms. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 211020 (Bupropion Hydrochloride), held by Graviti Pharms, was first approved by FDA on Jan 28, 2019, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2019
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
Jan 28, 2019	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


May 29, 2026	Supplement 28Labeling · Standard review	Approved	None posted
May 29, 2026	Supplement 29Labeling · Standard review	Approved	None posted
Mar 19, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Jun 15, 2022	Supplement 11Manufacturing	Approved	None posted
Jun 14, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jun 14, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Jun 30, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jan 28, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 211020
Drugs@FDA: Overview at FDA
Company: Graviti 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