ERIBULIN MESYLATE | A214310 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - ERIBULIN MESYLATE injection, for intravenous use RE Suitabilit... FDA-2023-P-5135 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Eribulin Mesylate injection for intravenous use, requesting FDA guidance on the regulatory pathway and requirements for developing a generic version of this product. | Suitability | 2023-11-20 | Open | Hyman |
Attachment 2 - HALAVEN- eribulin mesylate injection RE Suitability Petition f... FDA-2023-P-5135 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding HALAVEN (eribulin mesylate injection), requesting FDA evaluation of the product's suitability for regulatory purposes under applicable standards. | Suitability | 2023-11-20 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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