Bupropion Hydrochloride

ANDA 91459, held by Ph Health. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 91459 (Bupropion Hydrochloride), held by Ph Health, was first approved by FDA on Jun 9, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2011
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 9, 2011	Original application	Approved	None posted

Products

3 strengths and forms


Bupropion Hydrochloride100MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued
Bupropion Hydrochloride150MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued
Bupropion Hydrochloride200MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Dec 5, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Dec 5, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Dec 5, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Dec 5, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Apr 28, 2017	Supplement 9Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 2Labeling	Approved	None posted
Jun 9, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91459
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