← FDA DRUG APPROVALS

FDA ANDA · ANDA202304

BUPROPION HYDROCHLORIDE SR

bupropion hydrochloride

Sponsor: PRINSTON INC

APPLICATION
ANDA202304
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-26
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

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

Approval history

2025-01-29Labeling · Supplement 17 · standardAP
2024-02-15Labeling · Supplement 16 · standardAP
2022-08-09Labeling · Supplement 14 · standardAP
2021-03-12Labeling · Supplement 11 · standardAP
2021-03-12Labeling · Supplement 12 · standardAP
2017-12-14Labeling · Supplement 9 · standardAP
2017-12-14Labeling · Supplement 10 · standardAP
2017-12-14Labeling · Supplement 4 · standardAP
2015-05-26UNKNOWN · OriginalAP
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 →