Regulatory UpdatesSep 25, 2026•1 min read

FDA Approves ANDA079164 for Flecainide Acetate Tablets by Chartwell RX

By the PharmaCountry team

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.

Compiled by the PharmaCountry team · Source: FDA.gov

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