TOPIRAMATE | N020505 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - Approved labeling for reference-listed drug Topamax (Topiramat... FDA-2023-P-4295 Newcastle Bioscience, LLC filed a Citizen Petition seeking FDA confirmation that Topamax (topiramate) tablets by Janssen is a suitable reference-listed drug for purposes of establishing bioequivalence in generic drug applications. The petition requests that the FDA designate this product as appropri | Suitability | 2023-10-02 | Open | Newcastle Bioscience |
Attachment 2 - Draft Insert Label for Topiramate Orally Disintegrating Tablet... FDA-2023-P-4295 Newcastle Bioscience, LLC filed a petition regarding topiramate orally disintegrating tablets, requesting FDA review and approval of a draft insert label for this formulation as part of a suitability petition process. | Suitability | 2023-10-02 | Open | Newcastle Bioscience |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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