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Geschäft · 10.4.20261 Min. Lesezeit
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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Zusammenfassung
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →