HYDROXYZINE HYDROCHLORIDE | A087294 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Apozeal Pharmaceuticals Inc. FDA-2025-P-2611 Apozeal Pharmaceuticals Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Hydroxyzine Hydrochloride Oral Solution, 25 mg/5 mL, is suitable for submission in an ANDA. The petition seeks approval to market | Suitability | 2025-07-24 | Open | Apozeal Pharmaceuticals Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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