TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | N202158 | NORTHSTAR MEDICAL RADIOISOTOPES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamra, P.C. FDA-2023-P-0232 · 3 docket documents Curium US LLC filed this citizen petition on January 20, 2023, requesting that FDA refuse to approve any NDA or 505(b)(2) NDA for Technetium-99m produced in conventional generators using neutron capture technology with single-column chromatographic-based separation systems containing less than 2 gra | 505(q) | 2023-01-23 | Partially Denied | Hyman, Phelps & McNamra, P.C. |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2022-P-2702 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that FDA refuse to approve any New Drug Application or 505(b)(2) NDA for Technetium-99m produced using conventional generators employing neutron capture technology and aluminum oxide column-based separation systems, arguing that t | 505(q) | 2022-10-31 | Denied | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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