CLEMASTINE FUMARATE | A073283 | GENUS LIFESCIENCES INC
| 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 |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4330 Pharmobedient Consulting, LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA determine that Clemastine Fumarate Orally Disintegrating Tablets 2.68 mg is suitable for submission in an ANDA, based on | Suitability | 2023-10-03 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.