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Entreprise · 21/08/19951 min de lecture
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Monograph for OTC Bronchodilator Drug Products; Correction
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Résumé
The Food and Drug Administration (FDA) is correcting a proposal that appeared in the Federal Register of July 27, 1995 (60 FR 38643). That document proposed to amend the final monograph for over- the-counter (OTC) bronchodilator drug products to remove the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine hydrochloride and to classify these ingredients as not generally recognized as safe and effective for OTC use. The document was published with two errors. This document corrects those errors.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →