Bupropion Hydrochloride

ANDA 203650, held by Sun Pharm. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 203650 (Bupropion Hydrochloride), held by Sun Pharm, was first approved by FDA on Dec 31, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2020
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 31, 2020	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bupropion Hydrochloride300MG · tablet, extended release;oral	Bupropion Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Oct 10, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Jan 5, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Dec 31, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 203650
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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