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Entreprise · 29/09/20251 min de lecture
Determination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Résumé
The Food and Drug Administration (FDA or Agency) has determined that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg, if all other legal and regulatory requirements are met.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →