APPLICATION
ANDA201567
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-17
LATEST ACTION
2025-03-06
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
2025-03-06Labeling · Supplement 16 · standardAP
2022-12-13Labeling · Supplement 14 · standardAP
2022-12-13Labeling · Supplement 15 · standardAP
2020-03-05Labeling · Supplement 13 · standardAP
2018-07-23Labeling · Supplement 11 · standardAP
2018-07-23Labeling · Supplement 10 · standardAP
2018-07-23Labeling · Supplement 9 · standardAP
2015-11-10Labeling · Supplement 5 · standardAP
2014-11-20Labeling · Supplement 4 · standardAP
2014-01-17Not Applicable · OriginalAP
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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