ANDA 212312, held by Tris Pharma Inc. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 212312 (Sildenafil Citrate), held by Tris Pharma Inc, was first approved by FDA on Nov 17, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sildenafil CitrateEQ 10MG BASE/ML ยท for suspension;oral | Sildenafil Citrate | Discontinued |
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
