CLEMASTINE FUMARATE | N020925 | HALEON US HOLDINGS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6088 Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Clemastine Fumarate Tablets in 1.34 mg and 0.67 mg strengths suitable for submission as an ANDA for prescription use, with the referenc | Suitability | 2025-11-13 | Open | Hyman |
Attachment 3 CLEMASTINE FUMARATE Description Draft re Suitability Petition fr... FDA-2023-P-4292 Pharmobedient Consulting LLC filed a suitability petition regarding clemastine fumarate, requesting FDA assessment of the drug's suitability for development as a pharmaceutical product. | Suitability | 2023-10-03 | Open | Pharmobedient Consulting LLC |
Attachment 1 -Orange Book -TAVIST (Clemastine Fumarate) re Suitability Petiti... FDA-2023-P-4330 Pharmobedient Consulting, LLC filed a citizen petition regarding clemastine fumarate, the active ingredient in TAVIST, requesting a determination of suitability for abbreviated new drug application (ANDA) filing under the Orange Book regulatory framework. | Suitability | 2023-10-03 | Open | Pharmobedient Consulting |
Attachment 2 CLEMASTINE FUMARATE Description re Suitability Petition from Pha... FDA-2023-P-4292 Pharmobedient Consulting LLC filed a suitability petition regarding clemastine fumarate, requesting a determination of the drug's suitability for inclusion in an abbreviated new drug application or generic drug product development program. | Suitability | 2023-10-03 | Open | Pharmobedient Consulting LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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