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Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090038

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NDA 090038 describes MILRINONE LACTATE IN PLASTIC CONTAINER, which is a drug marketed by Hikma Farmaceutica and is included in one NDA. It is available from one supplier. Additional details are available on the MILRINONE LACTATE IN PLASTIC CONTAINER profile page.

The generic ingredient in MILRINONE LACTATE IN PLASTIC CONTAINER is milrinone lactate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.
Summary for 090038
Tradename:MILRINONE LACTATE IN PLASTIC CONTAINER
Applicant:Hikma Farmaceutica
Ingredient:milrinone lactate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090038
Suppliers and Packaging for NDA: 090038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MILRINONE LACTATE IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 090038 ANDA West-Ward Pharmaceuticals Corp 0143-9718 N 0143-9718-10
MILRINONE LACTATE IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 090038 ANDA West-Ward Pharmaceuticals Corp 0143-9719 N 0143-9719-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
Approval Date:Jan 21, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
Approval Date:Jan 21, 2010TE:APRLD:No

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