← FDA DRUG APPROVALS

FDA NDA · NDA022108

APLENZIN

bupropion hydrobromide

Sponsor: BAUSCH

APPLICATION
NDA022108
TYPE
NDA
ORIGINAL APPROVAL
2008-04-23
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

APLENZIN · ReferencePrescription
BUPROPION HYDROBROMIDE 348MG · TABLET, EXTENDED RELEASE · ORAL
APLENZIN · ReferencePrescription
BUPROPION HYDROBROMIDE 522MG · TABLET, EXTENDED RELEASE · ORAL
APLENZIN · ReferencePrescription
BUPROPION HYDROBROMIDE 174MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-11-05Labeling · Supplement 26 · standard — Letter ↗AP
2024-05-07Labeling · Supplement 23 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 22 · standard — Letter ↗AP
2021-07-08Labeling · Supplement 21 · standard — Letter ↗AP
2020-05-01Labeling · Supplement 20 · standard — Label ↗AP
2017-05-04Labeling · Supplement 14 · standard — Label ↗AP
2016-08-30Labeling · Supplement 12 · standard — Letter ↗AP
2014-12-30Labeling · Supplement 9 · standard — Label ↗AP
2014-07-09Labeling · Supplement 11 · 901 required — Label ↗AP
2012-08-15Efficacy · Supplement 7 · standard — Label ↗AP
2011-07-26Labeling · Supplement 6 · standard — Label ↗AP
2011-07-26Labeling · Supplement 5 · standard — Label ↗AP
2011-04-29REMS · Supplement 2 — Letter ↗AP
2011-04-29Labeling · Supplement 3 · 901 required — Letter ↗AP
2008-04-23Type 2 - New Active Ingredient · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →