Treats erectile dysfunction. ANDA 208494, held by Reyoung. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 208494 (Sildenafil Citrate), held by Reyoung, was first approved by FDA on Jun 12, 2020, with 0 approved supplements and 0 published complete response letters.
SILDENAFIL TABLETS is indicated for the treatment of erectile dysfunction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2020 | Original application | Approved | None posted |
| Sildenafil CitrateEQ 25MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Sildenafil CitrateEQ 50MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Sildenafil CitrateEQ 100MG BASE · tablet;oral | Sildenafil Citrate | Rx |
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
