Esta tradução está a ser preparada. Entretanto, mostramos temporariamente a versão original em inglês.
Negócios · 06/06/20231 min de leitura
Vintage Pharmaceuticals; Withdrawal of Approval of Abbreviated New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 075328 for pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811 (Vintage). Vintage requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →