Treats erectile dysfunction. ANDA 202255, held by Macleods Pharms. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 202255 (Sildenafil Citrate), held by Macleods Pharms, was first approved by FDA on Apr 19, 2023, with 0 approved supplements and 0 published complete response letters.
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2023 | 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
