Bupropion Hydrochloride

ANDA 202774, held by Jubilant Generics. Bupropion Hydrochloride.

As of Nov 15, 2026, ANDA 202774 (Bupropion Hydrochloride), held by Jubilant Generics, was first approved by FDA on Oct 11, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 11, 2013
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
Oct 11, 2013	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 3 submissions, including labeling and manufacturing supplements


Nov 20, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Oct 11, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202774
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