ANDA 212260, held by Novitium Pharma. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 212260 (Sildenafil Citrate), held by Novitium Pharma, was first approved by FDA on May 31, 2019, with 2 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 31, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sildenafil CitrateEQ 10MG BASE/ML · for suspension;oral | Sildenafil Citrate | Rx |
| Jul 8, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Feb 10, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 31, 2019 | Original application | Approved |
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
