TOPIRAMATE | N020844 | 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 |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0674 On behalf of a client, the law firm Hyman, Phelps & McNamara, P.C. filed a Suitability Petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Topiramate Capsules in 75 mg, 100 mg, 125 mg, 150 mg, and 200 mg strengths suitable for submission in | Suitability | 2021-07-08 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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