Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP

摘要

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205864 and the new animal drug application (NADA) 141-395 for the designated medical gas Helium, USP held by Air Products and Chemicals, Inc., 1940 Air Products Blvd., Allentown, PA 18106-5500 (Air Products). Air Products notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.