Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20
The Food and Drug Administration (FDA or Agency) has determined that CHEWTADZY (tadalafil) chewable tablets, 5 milligrams (mg), 10 mg, 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tadalafil, chewabl
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-04-16 |
| Summary | The Food and Drug Administration (FDA or Agency) has determined that CHEWTADZY (tadalafil) chewable tablets, 5 milligrams (mg), 10 mg, 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tadalafil, chewable tablets, 5 mg, 10 mg, 20 mg, if all other legal and regulatory requirements are met. |
| Document number | 2026-07443 |
| Official record | https://www.federalregister.gov/documents/2026/04/16/2026-07443/determination-that-chewtadzy-tadalafil-chewable-tablets-5-milligrams-10-milligrams-20-milligrams |