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FDA ANDA · ANDA211347

BUPROPION HYDROCHLORIDE SR

bupropion hydrochloride

Sponsor: YICHANG HUMANWELL

APPLICATION
ANDA211347
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-16
LATEST ACTION
2026-03-30
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

2026-03-30Labeling · Supplement 16 · standardAP
2025-09-19Labeling · Supplement 15 · standardAP
2025-09-19Labeling · Supplement 13 · standardAP
2025-09-19Labeling · Supplement 11 · standardAP
2023-07-10Labeling · Supplement 10 · standardAP
2022-06-23Labeling · Supplement 9 · standardAP
2020-12-21Labeling · Supplement 4 · standardAP
2020-09-28Labeling · Supplement 1 · standardAP
2018-10-16UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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.

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