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PHYTONADIONE

PHYTONADIONE INJECTION These highlights do not include all the information needed to use PHYTONADIONE INJECTABLE EMULSION, USP safely and effectively. See full prescribing information for PHYTONADIONE INJECTABLE EMULSION, USP. PHYTONADIONE Injection, for intravenous, intramuscular, and subcutaneous use. Initial U.S. Approval: 1960

Approved
Approval ID

0d971993-466c-46dd-bdd6-2e300173621e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 13, 2023

Manufacturers
FDA

Henry Schein, Inc.

DUNS: 012430880

Products 1

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

phytonadione

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0404-9935
Application NumberANDA083722
Product Classification
M
Marketing Category
C73584
G
Generic Name
phytonadione
Product Specifications
Route of AdministrationPARENTERAL
Effective DateNovember 13, 2023
FDA Product Classification

INGREDIENTS (1)

PHYTONADIONEActive
Quantity: 1 mg in 0.5 mL
Code: A034SE7857
Classification: ACTIB

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PHYTONADIONE - FDA Drug Approval Details