TADALAFIL | N218527 | B BETTER LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-4154 · 5 docket documents Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, petitioned the FDA under sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. sections 314.122 and 314.161 to determine whether Chewtadzy (tadalafil) chewable tablets in 5 mg, 10 mg, and 20 mg strengths, | 505(q) | 2025-09-23 | Granted | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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