ANDA 202597, held by Dr Reddys Labs Ltd. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 202597 (Sildenafil Citrate), held by Dr Reddys Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2012 | Original application | Tentative approval | None posted |
| Sildenafil Citrate25MG · tablet; oral | Sildenafil Citrate | None (tentative approval) |
| Sildenafil Citrate50MG · tablet; oral | Sildenafil Citrate | None (tentative approval) |
| Sildenafil Citrate100MG · tablet; oral | Sildenafil Citrate | None (tentative approval) |
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
