Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Chartwell Rx ×
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
FDA Approves ANDA079164 for Flecainide Acetate Tablets by Chartwell RX
The FDA approved the abbreviated new drug application ANDA079164 for Flecainide Acetate tablets (50 mg, 100 mg, 150 mg) from Chartwell RX, though the products are currently listed as discontinued.
Actualizaciones regulatorias
12 sept 2026•1 min de lectura
FDA Approves ANDA212957 for Fosaprepitant Dimeglumine (Discontinued Product)
The FDA granted approval (status AP) for ANDA212957 submitted by Chartwell Rx for the intravenous powder Fosaprepitant Dimeglumine, which is listed as discontinued.
Actualizaciones regulatorias
11 sept 2026•1 min de lectura
FDA Approves Chartwell RX Levofloxacin Oral Tablets (ANDA 076890)
The FDA has granted approval for Chartwell RX’s levofloxacin tablets in 250 mg, 500 mg and 750 mg oral strengths under ANDA 076890.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA Approves CILOSTAZOL Tablets (ANDA077831)
FDA has approved Chartwell Rx's ANDA077831 for oral CILOSTAZOL tablets in 50 mg and 100 mg strengths, with labeling updates approved in 2016.