Questa traduzione è in preparazione. Nel frattempo mostriamo temporaneamente la versione originale in inglese.
Imprese · 06/06/20231 min di lettura
Vintage Pharmaceuticals; Withdrawal of Approval of Abbreviated New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
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 Vintage requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →