Bupropion Hydrochloride

ANDA 76834, held by Chartwell Rx. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 76834 (Bupropion Hydrochloride), held by Chartwell Rx, was first approved by FDA on Jul 14, 2005, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2005
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 14, 2005	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Nov 6, 2025	Supplement 17Labeling · Standard review	Approved	None posted
May 7, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Apr 15, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Jan 16, 2008	Supplement 7Labeling	Approved	None posted
Jan 16, 2008	Supplement 10Labeling	Approved	None posted
Feb 9, 2007	Supplement 4Labeling	Approved	None posted
Jul 14, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76834
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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