Regulatory Updates
Sep 25, 2026•1 min read
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.
Regulatory Updates
Sep 12, 2026•1 min read
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.
Regulatory Updates
Sep 11, 2026•1 min read
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.
Regulatory Updates
Aug 30, 2026•1 min read
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.