Treats erectile dysfunction. ANDA 216383, held by Novitium Pharma. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 216383 (Sildenafil Citrate), held by Novitium Pharma, was first approved by FDA on Aug 29, 2023, with 0 approved supplements and 0 published complete response letters.
Sildenafil is indicated for the treatment of erectile dysfunction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 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
