ANDA 203988, held by Eugia Pharma. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 203988 (Sildenafil Citrate), held by Eugia Pharma, was first approved by FDA on Apr 1, 2015, with 2 approved supplements and 0 published complete response letters.
Adults Sildenafil injection 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 Patients (1 to 17 Years Old) Sildenafil injection is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sildenafil CitrateEQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) · solution;intravenous | Sildenafil Citrate | Rx |
| Oct 22, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 19, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 1, 2015 | Original application | Approved | None posted |
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
