CLEMASTINE FUMARATE | A073399 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6024 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 Oral Syrup in three new strengths of 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL suitable for submissi | Suitability | 2025-11-12 | Open | Hyman |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4292 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act requesting that the FDA declare Clemastine Powder for Solution in 1 mg and 2 mg Base per sachet suitable for submission in an ANDA, with the reference standard being the discontinued TAVIST oral s | Suitability | 2023-10-03 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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