CLEMASTINE FUMARATE | A073283 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6088 · 8 docket documents 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 | Denied | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4330 · 9 docket documents 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 | Denied | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.31
per ea
Lowest NADAC/Unit
$3.31
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 71085008130CLEMSZA 2.68 MG TABLET | $3.31 | EA | Generic | — | 2026-06-17 |
| 64950026810CLEMASTINE FUM 2.68 MG TABLET | $3.31 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.