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Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

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UPDATED
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
FOSPHENYTOIN SODIUM (ANDA078736) FDA Approval
FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.
UPDATED
Actualizaciones regulatorias
24 ago 2026•1 min de lectura
FDA Approves ANDA078070 for Valacyclovir Hydrochloride Tablets by Pharmobedient
The FDA approved application ANDA078070 submitted by Pharmobedient for oral valacyclovir hydrochloride tablets (500 mg and 1 g equivalents). Both products are listed as discontinued.