Treats erectile dysfunction. ANDA 218045, held by Cadila Pharms Ltd. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 218045 (Sildenafil Citrate), held by Cadila Pharms Ltd, was first approved by FDA on Nov 28, 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 |
|---|---|---|---|
| Nov 28, 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
