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Generated: November 21, 2018

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Details for New Drug Application (NDA): 204300

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NDA 204300 describes VAZCULEP, which is a drug marketed by Avadel Legacy and is included in one NDA. It is available from three suppliers. Additional details are available on the VAZCULEP profile page.

The generic ingredient in VAZCULEP is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.
Summary for 204300
Tradename:VAZCULEP
Applicant:Avadel Legacy
Ingredient:phenylephrine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204300
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 204300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VAZCULEP phenylephrine hydrochloride SOLUTION;INTRAVENOUS 204300 NDA BluePoint Laboratories 68001-331 68001-331-65 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-331-65) > 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
VAZCULEP phenylephrine hydrochloride SOLUTION;INTRAVENOUS 204300 NDA Medical Purchasing Solutions, LLC 71872-7042 71872-7042-1 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7042-1) > 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/ML (10MG/ML)
Approval Date:Jun 27, 2014TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/5ML (10MG/ML)
Approval Date:Jun 27, 2014TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/10ML (10MG/ML)
Approval Date:Jun 27, 2014TE:APRLD:Yes

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