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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-five 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:
VENOFER
Applicant:
Luitpold
Ingredient:
iron sucrose
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
Regulatory Exclusivity Expiration:Sep 21, 2015
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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:No
Regulatory Exclusivity Expiration:Sep 21, 2015
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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