All regulations
Nonrulemaking
FDA
FDA-2025-P-4154
Request that the FDA determine whether Chewtadzy (tadalafil) Chewable Tablets, 5 mg, 10 mg, and 20 mg, approved under New Drug Application (NDA) number 218527, held by B Better, LLC, has been voluntarily withdrawn for reasons of safety or effectiveness
Documents
5
Comments
0
Description
CLOSED
Key Dates
Comment Period OpensSep 23, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Chewtadzy (tadalafil) Chewable Tablets
5 mg, 10 mg, and 20 mg, approved under
New Drug Application (NDA) number 218527
as been voluntarily withdrawn for
reasons of safety or effectiveness
CLOSED
Data from Regulations.gov