GADOTERATE MEGLUMINE | N204781 | GUERBET LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from GE Healthcare Inc FDA-2017-P-4249 · 6 docket documents GE Healthcare Inc. filed this suitability petition under section 505(j)(2)(c) requesting FDA approval to add a 5mL vial size for its proposed generic drug product Clariscan (gadoterate meglumine) Injection, a gadolinium-based contrast agent for intravenous use in magnetic resonance imaging, to addre | Suitability | 2017-07-14 | Withdrawn | GE Healthcare Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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