RIZATRIPTAN BENZOATE | N020864 | ORGANON LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2025-P-1465 Newcastle Bioscience LLC filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Rizatriptan Benzoate Tablets 7.5 mg suitable for submission as an abbreviated new drug application, with Maxalt (Rizatriptan Benzoate) Tablets 1 | Suitability | 2025-05-30 | Open | Newcastle Bioscience LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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