Bupropion Hydrochloride

ANDA 75913, held by Impax Labs. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 75913 (Bupropion Hydrochloride), held by Impax Labs, was first approved by FDA on Jan 28, 2004, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2004
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 28, 2004	Original application	Approved	Review Letter

Products

2 strengths and forms


Bupropion Hydrochloride100MG · tablet, extended release;oral	Bupropion Hydrochloride	Rx
Bupropion Hydrochloride150MG · tablet, extended release;oral	Bupropion Hydrochloride	Rx

All 14 submissions, including labeling and manufacturing supplements


Jan 16, 2024	Supplement 37Labeling · Standard review	Approved	None posted
Sep 2, 2022	Supplement 35Labeling · Standard review	Approved	None posted
Sep 2, 2022	Supplement 36Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 23Labeling · Standard review	Approved	None posted
Oct 21, 2011	Supplement 20Labeling	Approved	None posted
Oct 21, 2011	Supplement 21Labeling	Approved	None posted
Aug 2, 2010	Supplement 19Labeling	Approved	None posted
May 24, 2010	Supplement 18Labeling	Approved	None posted
May 10, 2010	Supplement 17REMS	Approved	None posted
Apr 5, 2010	Supplement 16Labeling	Approved	None posted
Mar 22, 2004	Supplement 1	Approved	Review
Mar 22, 2004	Supplement 2	Approved	Review
Mar 22, 2004	Supplement 3Labeling	Approved	Review
Jan 28, 2004	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75913
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