DESFERAL- deferoxamine mesylate injection, powder, for solution

Desferal by

Drug Labeling and Warnings

Desferal by is a Prescription medication manufactured, distributed, or labeled by MITEM PHARMA, Excella GmbH & Co. KG Nürnberger Str. 12 90537 Feucht Germany, Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland, SGS International Services Laboratory (ISL) Limited Ringaskiddy Cork, P43 FR 63 Ireland (IRL), SGS Institut Fresenius GmbH Tegeler Weg 33 10589 Berlin Germany, SGS Institut Fresenius GmbH Im Maisel 14 65232 Taunusstein Germany, Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein Switzerland, Pharmanalytica SA Via Balestra 6600 Locarno Switzerland, Packaging Coordinators, LLC 3001 Red Lion Road Philadelphia, PA 19114, Wasserburger Arzneimittelwerk GmbH Herderstraβe 1,2 and Molkerei-Bauer-Straβe 18 83512 Wasserburg Germany, Labor LS SE & Co. KG Mangelsfeld 4, 5, 6, Bad Bocklet, Bavaria 97708 Germany, Solvias AG Römerpark 2 4303 Kaiseraugst Switzerland. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

DOSAGE FORMS & STRENGTHS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

OVERDOSAGE

DESCRIPTION

CLINICAL PHARMACOLOGY

NONCLINICAL TOXICOLOGY

HOW SUPPLIED

88436-1 - Section Title Not Found In Database

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DESFERAL 
deferoxamine mesylate injection, powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87081-467
Route of Administration	SUBCUTANEOUS, INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEFEROXAMINE MESYLATE (UNII: V9TKO7EO6K) (DEFEROXAMINE - UNII:J06Y7MXW4D)	DEFEROXAMINE MESYLATE	500 mg  in 5 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87081-467-91	4 mL in 1 VIAL; Type 0: Not a Combination Product	04/02/1968

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016267	04/02/1968

Labeler - MITEM PHARMA (500300624)

Establishment
Name	Address	ID/FEI	Business Operations
Excella GmbH & Co. KG Nürnberger Str. 12 90537 Feucht Germany		329809800	api manufacture(87081-467) , analysis(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland		482347168	analysis(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
SGS International Services Laboratory (ISL) Limited Ringaskiddy Cork, P43 FR 63 Ireland (IRL)		985785798	analysis(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
SGS Institut Fresenius GmbH Tegeler Weg 33 10589 Berlin Germany		341259550	analysis(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
SGS Institut Fresenius GmbH Im Maisel 14 65232 Taunusstein Germany		317219699	analysis(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein Switzerland		488152505	manufacture(87081-467) , analysis(87081-467) , pack(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmanalytica SA Via Balestra 6600 Locarno Switzerland		487967499	analysis(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
Packaging Coordinators, LLC 3001 Red Lion Road Philadelphia, PA 19114		078525133	pack(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
Wasserburger Arzneimittelwerk GmbH Herderstraβe 1,2 and Molkerei-Bauer-Straβe 18 83512 Wasserburg Germany		326482247	manufacture(87081-467) , analysis(87081-467) , pack(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
Labor LS SE & Co. KG Mangelsfeld 4, 5, 6, Bad Bocklet, Bavaria 97708 Germany		314929072	analysis(87081-467)

Establishment
Name	Address	ID/FEI	Business Operations
Solvias AG Römerpark 2 4303 Kaiseraugst Switzerland		480739627	analysis(87081-467)