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FDA ANDA · ANDA210015
BUPROPION HYDROCHLORIDE XL
bupropion hydrochloride
Sponsor: YICHANG HUMANWELL
APPLICATION
ANDA210015
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-14
LATEST ACTION
2026-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-03-13Labeling · Supplement 31 · standardAP
2025-05-23Labeling · Supplement 21 · standardAP
2025-05-23Labeling · Supplement 28 · standardAP
2025-05-23Labeling · Supplement 22 · standardAP
2025-05-23Labeling · Supplement 25 · standardAP
2022-01-03Labeling · Supplement 15 · standardAP
2020-03-16Labeling · Supplement 4 · standardAP
2018-06-14UNKNOWN · Original · standardAP
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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