Treats erectile dysfunction. ANDA 202659, held by Hetero Labs Ltd V. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 202659 (Sildenafil Citrate), held by Hetero Labs Ltd V, was first approved by FDA on Jun 11, 2018, with 0 approved supplements and 0 published complete response letters.
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2018 | 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
