APPLICATION
ANDA211020
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-28
LATEST ACTION
2026-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-05-29Labeling · Supplement 29 · standardAP
2026-05-29Labeling · Supplement 28 · standardAP
2025-03-19Labeling · Supplement 25 · standardAP
2022-06-15Manufacturing (CMC) · Supplement 11 · unknownAP
2022-06-14Labeling · Supplement 12 · standardAP
2022-06-14Labeling · Supplement 9 · standardAP
2020-06-30Labeling · Supplement 4 · standardAP
2019-01-28UNKNOWN · 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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