Uniferon 200: Product Information

UNIFERON 200- iron dextran injection, solution
Pharmacosmos A/S

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.

Each ml contains 200 mg iron(III) as iron(III) hydroxide dextran complex and phenol as a preservative

Read the package leaflet before use

Keep out of the sight and reach of children.

For animal treatment only

Pigs (piglets)

Pharmacosmos A/S

Roervangsvej 30

DK-4300 Holbaek

Shelf life once opened: 28 days below 25°C

Withdraw period: Zero days

Protect from frost

Once opened, use by__/__/__

Batch:

EXP:

Uniferon® Customer Information Sheet

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Uniferon® ​ 200 NADA 134-708, Approved by FDA Package Insert

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uniferon® ​ 200 mg/ml

SOLUTION FOR INJECTION

Iron(III) as iron(III) hydroxide dextran complex

100 ml i.m., s.c.

PHARMACOSMOS

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UNIFERON 200
iron (iii) hydroxide dextran complex injection, solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:49442-7401
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON DEXTRAN (FERRIC CATION) FERRIC CATION 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL 5 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49442-7401-3 72 CARTON in 1 BOX contains a CARTON (49442-7401-2)
1 NDC:49442-7401-2 12 BOTTLE, GLASS in 1 CARTON This package is contained within the BOX (49442-7401-3) and contains a BOTTLE, GLASS (49442-7401-1)
1 NDC:49442-7401-1 100 mL in 1 BOTTLE, GLASS This package is contained within a CARTON (49442-7401-2) and a BOX (49442-7401-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/11/2020
Labeler — Pharmacosmos A/S (309706968)
Establishment
Name Address ID/FEI Operations
Pharmacosmos A/S 309706968 api manufacture

Revised: 11/2020 Pharmacosmos A/S

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