Bupropion Hydrochloride

ANDA 90942, held by Aurobindo Pharma USA. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 90942 (Bupropion Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Jul 14, 2010, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2010
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 14, 2010	Original application	Approved	None posted

Products

2 strengths and forms


Bupropion Hydrochloride150MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued
Bupropion Hydrochloride300MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 12, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Jun 12, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Dec 19, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Apr 26, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Jul 14, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90942
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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