UNIFERON 200 (iron- iii hydroxide dextran complex injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)

Available from:

Pharmacosmos A/S

Administration route:

INTRAMUSCULAR

Prescription type:

OTC

Therapeutic indications:

Each ml contains 200 mg iron(III) as iron(III) hydroxide dextran complex and phenol as a preservative Read the package leaflet before use

Authorization status:

unapproved drug other

Summary of Product characteristics

UNIFERON 200- IRON (III) HYDROXIDE DEXTRAN COMPLEX 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._
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UNIFERON 200 MG/ML SOLUTION FOR INJECTION IRON(III) AS IRON(III) HYDROXIDE
DEXTRAN
COMPLEX
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
®
®
UNIFERON 200 NADA 134-708, APPROVED BY FDA PACKAGE INSERT
®
UNIFERON 200 MG/ML
SOLUTION FOR INJECTION
Iron(III) as iron(III) hydroxide dextran complex
100 ml i.m., s.c.
PHARMACOSMOS
UNIFERON 200
iron (iii) hydroxide dextran complex injection, solution
PRODUCT INFORMATION
PRODUCT T YPE
OTC ANIMAL DRUG
ITE M CODE (SOURCE )
NDC:49 442-740 1
ROUTE OF ADMINISTRATION
INTRAMUSCULAR
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
IRO N DEXTRAN (UNII: 9 5HR524N2M) (FERRIC CATION - UNII:9 1O4LML6 11)
FERRIC CATION
20 0 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PHENO L (UNII: 339 NCG44TV)
5 mg in 1 mL
®
Pharmacosmos A/S
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:49 442-740 1-3
72 in 1 BOX
1
NDC:49 442-740 1-2
12 in 1 CARTON
1
NDC:49 442-740 1-1
10 0 mL in 1 BOTTLE, GLASS
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
11/11/20 20
LABELER -
Pharmacosmos A/S (309706968)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Pharmaco smo s A/S
30 9 70 6 9 6 8
api manufacture
Revised: 11/2020