Bupropion Hydrochloride

Treats major depressive disorder. ANDA 78866, held by Sun Pharm. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 78866 (Bupropion Hydrochloride), held by Sun Pharm, was first approved by FDA on Apr 6, 2010, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2010
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 6, 2010	Original application	Approved	None posted

Products

3 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Nov 26, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Nov 26, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Jun 21, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Jun 21, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Jun 21, 2023	Supplement 21Labeling · Standard review	Approved	None posted
Jun 21, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Apr 14, 2017	Supplement 11Labeling · Standard review	Approved	None posted
Apr 14, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Jul 28, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Apr 6, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78866
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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