All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-5535
Requests that the FDA determine whether Prednisolone Tablets, 5 mg, approved under Abbreviated New Drug Application number 080326, held by Heather, has been voluntarily withdrawn for reasons of safety or effectiveness.
Documents
5
Comments
0
Key Dates
Comment Period OpensOct 22, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Hyman Phelps and McNamara PC
determine whether Prednisolone Tablets
5 mg, approved under
Abbreviated New Drug Application number 080326
held by Heather
has been voluntarily
Data from Regulations.gov