Reduces blood pressure. NDA 209387, held by Exela Pharma. Sodium Nitroprusside.
As of Nov 13, 2026, NDA 209387 (Nipride Rtu In Sodium Chloride 0.9%), held by Exela Pharma, was first approved by FDA on Mar 8, 2017, with 2 approved supplements and 0 published complete response letters.
Sodium nitroprusside is a direct acting vasodilator indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 8, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Nipride Rtu In Sodium Chloride 0.9%50MG/100ML (0.5MG/ML) · solution;intravenous | Sodium Nitroprusside | RxReference drug |
| Nipride Rtu In Sodium Chloride 0.9%10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Sodium Nitroprusside | DiscontinuedReference drug |
| Nipride Rtu In Sodium Chloride 0.9%20MG/100ML (0.2MG/ML) · solution;intravenous | Sodium Nitroprusside | RxReference drug |
| Jul 13, 2018 | Supplement 4Manufacturing | Approved | |
| May 23, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Mar 8, 2017 | Original applicationNew formulation or manufacturer · Standard review | 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
