← FDA DRUG APPROVALS
FDA ANDA · ANDA090284
ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE
alfuzosin hydrochloride
Sponsor: INVAGEN PHARMS
APPLICATION
ANDA090284
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-17
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ALFUZOSIN HYDROCHLORIDEPrescription
ALFUZOSIN HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-11-12Labeling · Supplement 11 · standardAP
2025-11-12Labeling · Supplement 16 · standardAP
2015-01-13Labeling · Supplement 5 · standardAP
2015-01-13Labeling · Supplement 4 · standardAP
2012-01-17OriginalAP
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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