Actualités réglementaires25 sept. 2026•1 min de lecture

FDA Approves ANDA079164 for Flecainide Acetate Tablets by Chartwell RX

Par l'équipe PharmaCountry

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.

The U.S. Food and Drug Administration has granted approval for ANDA number ANDA079164 covering Flecainide Acetate tablets. The application was submitted by Chartwell RX, LLC (sponsor Chartwell) and received an approval status (AP) on July 9, 2009. The approved dosage forms are oral tablets in three strengths—50 mg, 100 mg, and 150 mg—identified by product numbers 001, 002, and 003 respectively. All three tablet listings are currently marked with a marketing status of “Discontinued,” indicating they are not presently marketed.

Compilé par l'équipe PharmaCountry · Source : FDA.gov

Sujets :#FDA #ANDA #Flecainide Acetate #Chartwell Rx #generic drug #regulatory