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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 210666

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NDA 210666 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Paragon Bioteck, Amneal, Fresenius Kabi Usa, Meitheal, Par Sterile Products, Riconpharma Llc, Sandoz Inc, West Ward Pharm Corp, Hi Tech, and Vintage, and is included in fourteen NDAs. It is available from fourteen suppliers. There is one patent protecting this drug. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE profile page.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 210666
Tradename:PHENYLEPHRINE HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:phenylephrine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210666
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 210666
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210666 ANDA Fresenius Kabi USA, LLC 63323-751 63323-751-13 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-751-13) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-751-03)
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210666 ANDA Fresenius Kabi USA, LLC 63323-751 63323-751-05 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-05) > 5 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/5ML (10MG/ML)
Approval Date:Jan 30, 2019TE:AP1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/10ML (10MG/ML)
Approval Date:Jan 30, 2019TE:AP1RLD:No

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