APPLICATION
ANDA077285
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-15
LATEST ACTION
2024-09-16
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
2024-09-16Labeling · Supplement 42 · standardAP
2024-09-16Labeling · Supplement 45 · standardAP
2023-08-02Labeling · Supplement 40 · standardAP
2023-08-02Labeling · Supplement 39 · standardAP
2020-10-07Labeling · Supplement 35 · standardAP
2017-06-12Labeling · Supplement 34 · standardAP
2015-02-25Labeling · Supplement 32 · standardAP
2015-02-25Labeling · Supplement 30 · standardAP
2013-04-30Labeling · Supplement 19 · standardAP
2013-03-11REMS · Supplement 20AP
2011-10-31Labeling · Supplement 17AP
2010-06-25REMS · Supplement 14AP
2009-12-15Labeling · Supplement 8AP
2008-11-26Manufacturing (CMC) · Supplement 5AP
2008-11-26Labeling · Supplement 4AP
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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