APPLICATION
ANDA202598
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-06
LATEST ACTION
2024-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SILDENAFIL CITRATEPrescription
SILDENAFIL CITRATE EQ 20MG BASE · TABLET · ORAL
Approval history
2024-08-13Labeling · Supplement 4 · standardAP
2016-01-15Labeling · Supplement 2 · standardAP
2012-12-10Labeling · Supplement 1 · 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.