APPLICATION
ANDA079060
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-30
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ALFUZOSIN HYDROCHLORIDEPrescription
ALFUZOSIN HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-07-01Manufacturing (CMC) · Supplement 20 · unknownAP
2022-09-15Labeling · Supplement 13 · standardAP
2018-12-07Labeling · Supplement 10 · standardAP
2015-01-14Labeling · Supplement 3 · standardAP
2015-01-14Labeling · Supplement 4 · standardAP
2012-08-30OriginalAP
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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