← FDA DRUG APPROVALS

FDA ANDA · ANDA077455

BUPROPION HYDROCHLORIDE

Sponsor: WATSON LABS INC

APPLICATION
ANDA077455
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-12
LATEST ACTION
2021-01-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-01-04Labeling · Supplement 27 · standardAP
2021-01-04Labeling · Supplement 25 · standardAP
2014-11-14Labeling · Supplement 24 · standardAP
2013-03-11REMS · Supplement 20AP
2012-04-16Labeling · Supplement 15AP
2010-07-19Labeling · Supplement 4AP
2010-06-22REMS · Supplement 11AP
2009-11-16Labeling · Supplement 10AP
2009-02-26Labeling · Supplement 7AP
2008-09-23Labeling · Supplement 1AP
2008-03-12Original — Other Important Information from FDA ↗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 →