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Milrinone Lactate in Dextrose

Milrinone Lactate in 5% Dextrose Injection(For Intravenous Use)

Approved
Approval ID

bb0157d0-a414-43fa-81e0-8c92d717f1b2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2020

Manufacturers
FDA

Sagent Pharmaceuticals

DUNS: 796852890

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Milrinone Lactate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25021-313
Application NumberANDA213585
Product Classification
M
Marketing Category
C73584
G
Generic Name
Milrinone Lactate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 20, 2020
FDA Product Classification

INGREDIENTS (5)

Milrinone LactateActive
Quantity: 0.2 mg in 1 mL
Code: 9K8XR81MO8
Classification: ACTIM
Lactic AcidInactive
Code: 33X04XA5AT
Classification: IACT
Dextrose MonohydrateInactive
Code: LX22YL083G
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT

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Milrinone Lactate in Dextrose - FDA Drug Approval Details