PREDNISOLONE | A080326 | HEATHER DRUG CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-5535 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and requesting that the FDA determine whether Prednisolone Tablets, 5 mg, approved under ANDA number 080326 and held by Heather, was voluntarily withdrawn for | 505(q) | 2025-10-22 | Granted | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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