Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Inhalation ×
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
FDA Approves AstraZeneca ISOETHARINE Inhalation (ANDA089615)
The FDA approved ANDA089615 for ISOETHARINE HYDROCHLORIDE inhalation solution (0.125%) by AstraZeneca. The product is listed as discontinued.
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
FDA Approves Nitrogen Inhalation Drug (NDA212315) for Prescription Use
The FDA has approved the prescription inhalation product NITROGEN, NF (NDA212315), a medical gas for respiratory use, sponsored by Universal Industrial Gases, Inc.
Actualizaciones regulatorias
18 sept 2026•1 min de lectura
FDA Approves NexAir’s Prescription Carbon Dioxide Inhalation Product (NDA215007)
The FDA’s NDA215007 for NexAir’s carbon dioxide inhalation gas (USP) is listed with approval status AP, detailing route, dosage form, and NDC codes.
Actualizaciones regulatorias
12 sept 2026•1 min de lectura
FDA Assigns NDA 214937 for Helium Inhalation Product by Westair Gases
The FDA has listed NDA 214937 for a prescription helium inhalation gas (HELIUM, USP) submitted by Westair Gases & Equipment Inc., with submission documents dated June‑July 2020.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
FDA Approves Apotex’s Albuterol Sulfate Inhalation Solution (ANDA 076391)
The FDA granted approval for Apotex Inc.’s ANDA 076391, an inhalation solution of albuterol sulfate, with original approval in 2003 and a labeling supplement in 2017.