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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 213585


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NDA 213585 describes MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Gland Pharma Ltd, Hikma, Hospira, West-ward Pharms Int, and Woodward, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER is milrinone lactate. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.
Summary for 213585
Tradename:MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Gland Pharma Ltd
Ingredient:milrinone lactate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213585
Mechanism of ActionPhosphodiesterase 3 Inhibitors
Suppliers and Packaging for NDA: 213585
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 213585 ANDA Hospira, Inc. 0409-1983 0409-1983-10 10 POUCH in 1 CARTON (0409-1983-10) / 1 BAG in 1 POUCH (0409-1983-01) / 200 mL in 1 BAG
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 213585 ANDA Hospira, Inc. 0409-2045 0409-2045-10 10 POUCH in 1 CARTON (0409-2045-10) / 1 BAG in 1 POUCH (0409-2045-01) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date:Jul 16, 2020TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date:Jul 16, 2020TE:APRLD:No

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