ANDA 215708, held by Zydus Lifesciences. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 215708 (Sildenafil Citrate), held by Zydus Lifesciences, was first approved by FDA on Sep 29, 2022, 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 Patients (1 to 17 Years Old) Sildenafil for oral suspension 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 |
|---|---|---|---|
| Sep 29, 2022 | Original application | Approved | None posted |
| 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
