Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#supplemental ×
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)
The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.
Actualizaciones regulatorias
15 sept 2026•1 min de lectura
FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)
FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.
Actualizaciones regulatorias
10 sept 2026•1 min de lectura
FDA NDA 007883: Antabuse (disulfiram) supplemental manufacturing and labeling submissions
The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.
Actualizaciones regulatorias
5 sept 2026•1 min de lectura
Quinapril Hydrochloride and Hydrochlorothiazide Tablets – FDA Labeling Approvals (ANDA 077093)
FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA Approves Supplemental ANDA 086178 for GLYCOPYRROLATE Tablet
FDA records approval of a supplemental manufacturing (CMC) submission for ANDA 086178, covering the oral GLYCOPYRROLATE 2 mg tablet by Watson Labs, now listed as discontinued.