Bupropion Hydrochloride

ANDA 91520, held by Ph Health. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 91520 (Bupropion Hydrochloride), held by Ph Health, was first approved by FDA on Jun 9, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2011
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
Jun 9, 2011	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 11Labeling · Standard review	Approved	None posted
May 7, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Aug 25, 2017	Supplement 7Labeling · Standard review	Approved	None posted
Aug 25, 2017	Supplement 8Labeling · Standard review	Approved	None posted
Aug 16, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Apr 23, 2012	Supplement 2Labeling	Approved	None posted
Jun 9, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91520
Drugs@FDA: Overview at FDA
Company: PH Health

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