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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021135

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NDA 021135 describes VENOFER, which is a drug marketed by Luitpold and is included in one NDA. It is available from two suppliers. Additional details are available on the VENOFER profile page.

The generic ingredient in VENOFER is iron sucrose. There are seventy-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iron sucrose profile page.

Summary for NDA: 021135

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 021135

Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity

Suppliers and Packaging for NDA: 021135

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENOFER
iron sucrose
INJECTABLE;INTRAVENOUS 021135 NDA American Regent, Inc. 0517-2310 0517-2310-05 5 VIAL, SINGLE-USE in 1 BOX (0517-2310-05) > 10 mL in 1 VIAL, SINGLE-USE
VENOFER
iron sucrose
INJECTABLE;INTRAVENOUS 021135 NDA American Regent, Inc. 0517-2325 0517-2325-10 10 VIAL, SINGLE-USE in 1 BOX (0517-2325-10) > 2.5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 100MG BASE/5ML (EQ 20MG BASE/ML)
Approval Date:Nov 6, 2000TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)
Approval Date:Mar 20, 2005TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)
Approval Date:Mar 29, 2005TE:RLD:No


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