Rx only

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.

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PHYTONADIONE
phytonadione injection, emulsion

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)	PHYTONADIONE	10 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76483-051-31	1 mL in 1 AMPULE; Type 0: Not a Combination Product	04/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/10/2018

PHYTONADIONE
phytonadione injection, emulsion

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)	PHYTONADIONE	1 mg in 0.5 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76483-052-30	0.5 mL in 1 AMPULE; Type 0: Not a Combination Product	04/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/10/2018

Labeler - Square Pharmaceuticals Ltd. (731487153)

Name	Address	ID/FEI	Business Operations
Establishment
Square Pharmaceuticals Ltd.		731487153	analysis(76483-051, 76483-052) , label(76483-051, 76483-052) , manufacture(76483-051, 76483-052) , pack(76483-051, 76483-052)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10mg/mL