APPLICATION
ANDA079054
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-18
LATEST ACTION
2022-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ALFUZOSIN HYDROCHLORIDEDiscontinued
ALFUZOSIN HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-09-15Labeling · Supplement 17 · standardAP
2018-12-07Labeling · Supplement 15 · standardAP
2015-01-15Labeling · Supplement 8 · standardAP
2015-01-15Labeling · Supplement 6 · standardAP
2015-01-15Labeling · Supplement 10 · standardAP
2014-11-18Manufacturing (CMC) · Supplement 4AP
2013-07-11Labeling · 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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