Treats erectile dysfunction. ANDA 209302, held by Umedica. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 209302 (Sildenafil Citrate), held by Umedica, was first approved by FDA on Aug 25, 2020, with 1 approved supplement and 0 published complete response letters.
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2020 | Original application | Approved | None posted |
| Sildenafil CitrateEQ 50MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Sildenafil CitrateEQ 100MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Sildenafil CitrateEQ 25MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Jun 15, 2021 | Supplement 3Manufacturing | Approved | None posted |
| Aug 25, 2020 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
