Bupropion Hydrochloride

ANDA 75914, held by Impax Labs. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 75914 (Bupropion Hydrochloride), held by Impax Labs, was first approved by FDA on May 27, 2004, with 11 approved supplements and 0 published complete response letters.

First approved: May 27, 2004
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
May 27, 2004	Original application	Approved	None posted

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


Nov 5, 2025	Supplement 33Labeling · Standard review	Approved	None posted
May 7, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Jun 6, 2022	Supplement 31Labeling · Standard review	Approved	None posted
Jun 30, 2017	Supplement 29Labeling · Standard review	Approved	None posted
Jan 4, 2016	Supplement 25Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 20Labeling · Standard review	Approved	None posted
Apr 10, 2012	Supplement 15Labeling	Approved	None posted
Jun 24, 2011	Supplement 14Labeling	Approved	None posted
May 13, 2010	Supplement 13REMS	Approved	None posted
Jan 25, 2010	Supplement 12Labeling	Approved	None posted
May 27, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 75914
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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