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FDA ANDA · ANDA206122
BUPROPION HYDROCHLORIDE (SR)
bupropion hydrochloride
Sponsor: SCIEGEN PHARMS
APPLICATION
ANDA206122
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-17
LATEST ACTION
2025-11-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-11-06Labeling · Supplement 19 · standardAP
2024-05-07Labeling · Supplement 16 · standardAP
2021-12-13Manufacturing (CMC) · Supplement 7 · unknownAP
2021-12-13Labeling · Supplement 5 · standardAP
2021-12-13Labeling · Supplement 3 · standardAP
2017-06-30Labeling · Supplement 1 · 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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