Bupropion Hydrochloride

ANDA 216766, held by Yichang Humanwell. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 216766 (Bupropion Hydrochloride), held by Yichang Humanwell, was first approved by FDA on Jan 9, 2023, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 9, 2023
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated as an aid to smoking cessation treatment.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 9, 2023	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Nov 5, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Sep 17, 2025	Supplement 3Labeling · Standard review	Approved	None posted
May 7, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Feb 12, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Jan 9, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 216766
Drugs@FDA: Overview at FDA
Company: Yichang Humanwell Pharmaceutical

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