ANDA 211534, held by Teva Pharms USA. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 211534 (Sildenafil Citrate), held by Teva Pharms USA, was first approved by FDA on May 29, 2020, with 0 approved supplements and 0 published complete response letters.
Adults Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sildenafil CitrateEQ 10MG BASE/ML · for suspension;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
