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FDA ANDA · ANDA076845

BUPROPION HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA076845
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-14
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
BUPROPION HYDROCHLORIDEDiscontinued
BUPROPION HYDROCHLORIDE 150MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-01-29Labeling · Supplement 10 · standardAP
2023-08-08Labeling · Supplement 9 · standardAP
2023-08-08Labeling · Supplement 8 · standardAP
2005-07-14Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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