ANDA 203144, held by Airgas Therap. Nitric Oxide.
As of Nov 14, 2026, ANDA 203144 (Ulspira), held by Airgas Therap, was first approved by FDA on Jul 27, 2023, with 0 approved supplements and 0 published complete response letters.
ULSPIRA is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ulspira800PPM · gas;inhalation | Nitric Oxide | 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
