PHYTONADIONE
PHYTONADIONE INJECTABLE EMULSION, USPAqueous Colloidal Solution of Vitamin K1Rx Only
Approved
Approval ID
4a4e56d0-b466-42d5-91ef-f4a33409bbc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2017
Manufacturers
FDA
General Injectables & Vaccines, Inc
DUNS: 108250663
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 Code52584-043
Application NumberANDA083722
Product Classification
M
Marketing Category
C73584
G
Generic Name
phytonadione
Product Specifications
Route of AdministrationPARENTERAL
Effective DateJanuary 12, 2017
FDA Product Classification
INGREDIENTS (1)
PHYTONADIONEActive
Quantity: 1 mg in 0.5 mL
Code: A034SE7857
Classification: ACTIB