Request that the FDA determine whether the drug product Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection; 40 mg/250 mL (160 mcg/mL) is suitable for submission in an ANDA. The listed drug upon which this petition is based is Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection; 20 mg/250 mL (80 mcg/mL), NDA 216830 owned by Dr. Reddy’s Laboratories SA. The Petitioner seeks a | Federal Regulations · Congress.wiki