APPLICATION
ANDA090325
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-08
LATEST ACTION
2025-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-01-10Labeling · Supplement 20 · standardAP
2025-01-10Labeling · Supplement 21 · standardAP
2020-12-21Labeling · Supplement 16 · standardAP
2020-12-21Labeling · Supplement 17 · standardAP
2020-12-21Labeling · Supplement 15 · standardAP
2017-06-12Labeling · Supplement 13 · standardAP
2015-09-11Labeling · Supplement 12 · standardAP
2015-09-11Labeling · Supplement 10 · standardAP
2014-02-07Labeling · Supplement 9 · standardAP
2014-02-07Labeling · Supplement 6 · standardAP
2013-07-02Manufacturing (CMC) · Supplement 8 · unknownAP
2011-08-08Manufacturing (CMC) · Supplement 5AP
2010-04-08OriginalAP
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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