APPLICATION
ANDA076711
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-03
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-01-29Labeling · Supplement 43 · standardAP
2023-08-08Labeling · Supplement 41 · standardAP
2023-08-08Labeling · Supplement 42 · standardAP
2021-01-04Labeling · Supplement 40 · standardAP
2021-01-04Labeling · Supplement 32 · standardAP
2021-01-04Labeling · Supplement 30 · standardAP
2021-01-04Labeling · Supplement 39 · standardAP
2021-01-04Labeling · Supplement 31 · standardAP
2015-09-29Labeling · Supplement 24 · standardAP
2015-09-29Labeling · Supplement 27 · standardAP
2015-09-29Labeling · Supplement 19 · standardAP
2015-09-29Labeling · Supplement 23 · standardAP
2012-02-21Labeling · Supplement 14AP
2012-02-21Labeling · Supplement 13AP
2010-08-18Labeling · Supplement 12AP
2010-07-08REMS · Supplement 11AP
2010-01-27Labeling · Supplement 9AP
2008-01-16Labeling · Supplement 7AP
2006-10-05Labeling · Supplement 5AP
2006-02-14Labeling · Supplement 3AP
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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