Requests that the FDA find the proposed drug product Phenylephrine Hydrochloride Injection, 1 mg/10 mL (0.1 mg/mL) in a pre-filled syringe is suitable for submission as an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-6257

Requests that the FDA find the proposed drug product Phenylephrine Hydrochloride Injection, 1 mg/10 mL (0.1 mg/mL) in a pre-filled syringe is suitable for submission as an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensJun 2, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Apotex Corp.	Jul 23, 2026	--

Keywords

CDER

Suitability Petition

Apotex Corp

find the proposed drug product

Phenylephrine Hydrochloride Injection

1 mg 10 mL 0.1 mg mL in

a pre-filled syringe is suitable for submission

as an Abbreviated New Drug Application

Data from Regulations.gov