← FDA DRUG APPROVALS

FDA ANDA · ANDA207459

BUPROPION HYDROCHLORIDE

Sponsor: JUBILANT GENERICS

APPLICATION
ANDA207459
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-30
LATEST ACTION
2020-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-09-14Labeling · Supplement 5 · standardAP
2020-09-14Labeling · Supplement 1 · standardAP
2017-06-30UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →