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FDA ANDA · ANDA216766

BUPROPION HYDROCHLORIDE SR

bupropion hydrochloride

Sponsor: YICHANG HUMANWELL

APPLICATION
ANDA216766
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-09
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

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

Approval history

2025-11-05Labeling · Supplement 4 · standardAP
2025-09-17Labeling · Supplement 3 · standardAP
2024-05-07Labeling · Supplement 2 · standardAP
2024-02-12Labeling · Supplement 1 · standardAP
2023-01-09UNKNOWN · 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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