APPLICATION
ANDA203814
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-17
LATEST ACTION
2025-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SILDENAFIL CITRATEPrescription
SILDENAFIL CITRATE EQ 20MG BASE · TABLET · ORAL
Approval history
2025-06-30Labeling · Supplement 29 · standardAP
2025-06-30Labeling · Supplement 27 · standardAP
2025-06-30Labeling · Supplement 23 · standardAP
2019-04-23Labeling · Supplement 12 · standardAP
2019-04-23Labeling · Supplement 9 · standardAP
2019-04-23Labeling · Supplement 5 · standardAP
2015-10-26Labeling · Supplement 2 · standardAP
2015-04-02Labeling · Supplement 1 · standardAP
2013-12-17UNKNOWN · 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.
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