Bu çeviri hazırlanıyor. Bu süre içinde İngilizce orijinal sürümü gösteriyoruz.
İş dünyası · 02.04.20181 dk okuma
Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications
Yerel otomatik çeviri · Kaynağın orijinal dili
Özet
The Commissioner of Food and Drugs (the Commissioner) is denying requests for a hearing and issuing an order withdrawing approval of abbreviated new drug applications (ANDAs) for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350), listed in this document, because the drug products are misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →