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Negocios · 10/4/20261 min de lectura
GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base
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Resumen
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA 19104 (GSK). GSK notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →