PHENYLEPHRINE HYDROCHLORIDE | N203826 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Apotex Corp. FDA-2026-P-6257 Apotex Corp. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Phenylephrine Hydrochloride Injection, 1 mg/10 mL (0.1 mg/mL) in a pre-filled syringe, a new parenteral strength | Suitability | 2026-06-02 | Open | Apotex Corp. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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