Ulspira

FDA Drug Profile — Ulspira

Drug Details

Generic Name
Ulspira
Brand Names
Ulspira
Application Number
ANDA203144
Sponsor
Airgas Therapeutics, LLC
NDC Codes
1
Dosage Forms
GAS
Routes
RESPIRATORY (INHALATION)
Active Ingredients
NITRIC OXIDE

Indications and Usage

1 INDICATIONS AND USAGE 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. ULSPIRA is a vasodilator 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.