Bupropion Hydrochloride

Treats major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). ANDA 200695, held by Sun Pharm. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 200695 (Bupropion Hydrochloride), held by Sun Pharm, was first approved by FDA on Dec 18, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 18, 2014
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bupropion hydrochloride extended-release tablets, USP (XL) are aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. 1.1 Major Depressive Disorder

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 18, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bupropion Hydrochloride150MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 23, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Aug 23, 2017	Supplement 3Labeling · Standard review	Approved	None posted
Sep 27, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Dec 18, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 200695
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