FDA ANDA · ANDA208652
BUPROPION HYDROCHLORIDE (XL)
bupropion hydrochloride
Sponsor: SINOTHERAPEUTICS INC
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APPLICATION
ANDA208652
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-21
LATEST ACTION
2026-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-05Labeling · Supplement 14 · standardAP
2024-12-17Labeling · Supplement 12 · standardAP
2024-12-17Labeling · Supplement 9 · standardAP
2024-12-17Labeling · Supplement 11 · standardAP
2020-06-30Labeling · Supplement 5 · standardAP
2017-08-21UNKNOWN · Original · standardAP
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