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Is Fildena CT 100 approved by the FDA?
Is Fildena CT 100 approved by the FDA?
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kirazmattson
560 posts
Jun 14, 2025
3:56 AM
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Fildena CT 100 mg, like many generic medications, contains Sildenafil Citrate as its active ingredient, which is also the active component in Viagra. However, when it comes to FDA approval, there are a few important distinctions to understand: FDA Approval for Sildenafil (Active Ingredient) Sildenafil Citrate, the active ingredient in Fildena CT 100 mg, is FDA-approved for use in the treatment of erectile dysfunction (ED) under the brand name Viagra. The FDA approved Viagra (brand-name Sildenafil) in 1998, and it remains the gold standard for treating ED. FDA Approval for Fildena CT 100 (Brand/Generic) Fildena CT 100 mg is not FDA-approved in the United States. It is a generic version of Viagra, typically produced and sold by manufacturers outside of the U.S., often in countries like India. Generic medications like Fildena CT 100 mg can be sold in countries where they have been approved by the respective regulatory authorities, such as the Indian Drug Regulatory Authority (CDSCO). However, generic versions of Sildenafil (such as Fildena CT 100 mg) are not automatically FDA-approved unless they undergo the FDA's approval process or are marketed under specific FDA-sanctioned generic regulations. Key Points to Note FDA-Approved Sildenafil: The FDA-approved versions of Sildenafil for erectile dysfunction are the brand names Viagra and FDA-approved generics sold through licensed U.S. pharmacies. Generic Sildenafil (like Fildena CT 100): Although Fildena CT 100 mg contains the same active ingredient as Viagra, it may not meet the same manufacturing standards required by the FDA for approval in the U.S. Generic medications sold outside the U.S. may vary in terms of manufacturing processes, purity, and quality control compared to those approved by the FDA.
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