Bupropion Hydrochloride

ANDA 202775, held by Jubilant Generics. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 202775 (Bupropion Hydrochloride), held by Jubilant Generics, was first approved by FDA on Oct 11, 2013, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 11, 2013
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
Oct 11, 2013	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 5, 2025	Supplement 16Labeling · Standard review	Approved	None posted
May 7, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Apr 10, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Apr 10, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Jun 14, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jun 14, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Oct 11, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202775
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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