ANDA 212440, held by Alkem Labs Ltd. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 212440 (Sildenafil Citrate), held by Alkem Labs Ltd, was first approved by FDA on Nov 27, 2019, with 1 approved supplement 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) 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 |
|---|---|---|---|
| Nov 27, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sildenafil CitrateEQ 10MG BASE/ML · for suspension;oral | Sildenafil Citrate | Rx |
| Apr 29, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 27, 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
