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Guest
Jul 17, 2025
1:57 AM
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Fildena CT 100?mg tablets contain sildenafil citrate, the same active ingredient found in FDA?approved drugs like Viagra and Revatio. However, Fildena CT itself is not FDA?approved. It’s a generic product manufactured outside the United States (likely India) and has not undergone the FDA's formal approval process.
1. Active ingredient
Sildenafil citrate—the key component in FILDENA CT 100 MG is FDA-approved for erectile dysfunction and pulmonary arterial hypertension. It gained approval in 1998 for ED and in a lower-dose form for PAH, with multiple generic manufacturers later added to the FDA’s list .
2. Product approval
Fildena CT is manufactured overseas and marketed as a generic chewable tablet. While many pharmacies describe it as containing “FDA-approved sildenafil,” this refers only to the ingredient, not the product itself . There is no record of Fildena CT having an FDA New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
3. Regulatory risks
The FDA cautions against using unapproved ED products sold online, stating they may have quality concerns and “dangerous dosages” .
If you're in the U.S. and seeking a safe, regulated ED treatment, it's best to use FDA?approved brands or generics—only those with proper FDA clearance.
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