Requests that the FDA declare that Phenylephrine Hydrochloride in 0.9% Sodium Chloride injection, 40 mg per 500 mL (0.08 mglmL), is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-6893

Requests that the FDA declare that Phenylephrine Hydrochloride in 0.9% Sodium Chloride injection, 40 mg per 500 mL (0.08 mglmL), is suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 10, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Sagent Pharmaceuticals	Jun 5, 2026	--

Keywords

CDER

Suitability Petition

Sagent Pharmaceuticals

declare that Phenylephrine Hydrochloride

in 0.9% Sodium Chloride injection

40 mg per 500 mL (0.08 mglmL)

is suitable for submission as an ANDA

Abbreviated New Drug Application

Data from Regulations.gov