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FDA ANDA · ANDA207224
BUPROPION HYDROCHLORIDE XL
bupropion hydrochloride
Sponsor: ANBISON LAB
APPLICATION
ANDA207224
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-30
LATEST ACTION
2024-10-07
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
2024-10-07Labeling · Supplement 7 · standardAP
2023-10-23Labeling · Supplement 5 · standardAP
2023-10-23Labeling · Supplement 6 · standardAP
2023-10-23Labeling · Supplement 4 · standardAP
2018-11-05Manufacturing (CMC) · Supplement 3 · unknownAP
2017-06-30UNKNOWN · 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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