Phytonadione

PHYTONADIONE- phytonadione injection, emulsion
Square Pharmaceuticals Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10mg/mL

10mg/mL
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1mg/0.5 mL

1mg/0.5mL
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PHYTONADIONE
phytonadione injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76483-051
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76483-051-31 1 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/10/2018
PHYTONADIONE
phytonadione injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76483-052
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 1 mg in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76483-052-30 0.5 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/10/2018
Labeler — Square Pharmaceuticals Ltd. (731487153)
Establishment
Name Address ID/FEI Operations
Square Pharmaceuticals Ltd. 731487153 analysis (76483-051), analysis (76483-052), label (76483-051), label (76483-052), manufacture (76483-051), manufacture (76483-052), pack (76483-051), pack (76483-052)

Revised: 04/2016 Square Pharmaceuticals Ltd.

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