Esta tradução está a ser preparada. Entretanto, mostramos temporariamente a versão original em inglês.
Negócios · 18/10/20241 min de leitura
Linde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205851 and the new animal drug application (NADA) 141-389 for the designated medical gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY 14150-7844. Linde, Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →