APPLICATION
ANDA202025
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-28
LATEST ACTION
2020-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SILDENAFIL CITRATEPrescription
SILDENAFIL CITRATE EQ 20MG BASE · TABLET · ORAL
Approval history
2020-01-15Labeling · Supplement 4 · standardAP
2020-01-15Labeling · Supplement 3 · standardAP
2016-10-17Labeling · Supplement 2 · standardAP
2015-03-18Labeling · Supplement 1 · standardAP
2013-02-28Not Applicable · OriginalAP
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.