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FDA ANDA · ANDA079095

BUPROPION HYDROCHLORIDE SR

bupropion hydrochloride

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA079095
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-24
LATEST ACTION
2020-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEPrescription
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-12-23Labeling · Supplement 26 · standardAP
2020-12-23Labeling · Supplement 30 · standardAP
2020-12-23Labeling · Supplement 33 · standardAP
2015-06-14Labeling · Supplement 20 · standardAP
2015-06-14Labeling · Supplement 21 · standardAP
2014-11-20Labeling · Supplement 16 · standardAP
2014-11-20Labeling · Supplement 13 · standardAP
2012-04-23Labeling · Supplement 11AP
2010-08-18Labeling · Supplement 9AP
2010-04-27REMS · Supplement 7AP
2009-11-16Labeling · Supplement 4AP
2009-03-24OriginalAP
VIEW ON DRUGS@FDA ↗

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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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