APPLICATION
ANDA210497
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-31
LATEST ACTION
2024-11-21
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
2024-11-21Manufacturing (CMC) · Supplement 6 · unknownAP
2022-12-13Labeling · Supplement 2 · standardAP
2022-12-13Labeling · Supplement 5 · standardAP
2018-10-31UNKNOWN · 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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