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FDA ANDA · ANDA205794

BUPROPION HYDROCHLORIDE SR

bupropion hydrochloride

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA205794
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-01
LATEST ACTION
2025-04-18
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

2025-04-18Labeling · Supplement 37 · standardAP
2025-04-18Labeling · Supplement 40 · standardAP
2023-07-28Labeling · Supplement 28 · standardAP
2020-12-22Labeling · Supplement 17 · standardAP
2020-12-22Labeling · Supplement 13 · standardAP
2017-11-03Labeling · Supplement 3 · standardAP
2017-04-17Labeling · Supplement 1 · standardAP
2016-03-01UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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