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Cerilliant
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US Department of Justice
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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021751

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NDA 021751 describes PENTETATE ZINC TRISODIUM, which is a drug marketed by Hameln Pharma Plus and is included in one NDA. It is available from one supplier. Additional details are available on the PENTETATE ZINC TRISODIUM profile page.

The generic ingredient in PENTETATE ZINC TRISODIUM is pentetate zinc trisodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pentetate zinc trisodium profile page.
Summary for 021751
Tradename:PENTETATE ZINC TRISODIUM
Applicant:Hameln Pharma Plus
Ingredient:pentetate zinc trisodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021751
Mechanism of ActionLead Chelating Activity
Suppliers and Packaging for NDA: 021751
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENTETATE ZINC TRISODIUM pentetate zinc trisodium SOLUTION;INHALATION, INTRAVENOUS 021751 NDA hameln pharma plus gmbh 70651-002 N 70651-002-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATION, INTRAVENOUSStrengthEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 11, 2004TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Farmers Insurance
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Medtronic

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