APPLICATION
ANDA079057
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-18
LATEST ACTION
2024-10-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ALFUZOSIN HYDROCHLORIDEDiscontinued
ALFUZOSIN HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-10-23Labeling · Supplement 22 · standardAP
2020-10-01Labeling · Supplement 18 · standardAP
2018-11-14Labeling · Supplement 12 · standardAP
2015-06-01Labeling · Supplement 9 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.