Fildena CT 50 mg itself is FDA-approved. The FDA has approved sildenafil 50 mg products, including Viagra and generic sildenafil tablets. For example, FDA records show approval of sildenafil citrate 25 mg, 50 mg, and 100 mg tablets as generic versions of Viagra. However, FDA approval of sildenafil does not mean that every brand containing sildenafil—such as Fildena CT 50 mg—is FDA-approved. I could not find an FDA approval record for the specific Fildena CT 50 mg brand. So, if you're checking the product's regulatory status, distinguish between: Sildenafil 50 mg: FDA-approved drug ingredient/product formulations exist. Fildena CT 50 mg: No FDA approval for this specific brand was established from the FDA sources checked. U.S. use: Sildenafil for ED is a prescription medicine, and FDA-approved labeling lists 50 mg as the usual starting dose for many patients. If you want, I can also explain whether Fildena CT 50 mg is approved/registered in India and which Indian regulator applies.