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Details for New Drug Application (NDA): 021749

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NDA 021749 describes PENTETATE CALCIUM 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 CALCIUM TRISODIUM profile page.

The generic ingredient in PENTETATE CALCIUM TRISODIUM is pentetate calcium 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 calcium trisodium profile page.

Summary for NDA: 021749

Hameln Pharma Plus
pentetate calcium trisodium
Formulation / Manufacturing:see details

Pharmacology for NDA: 021749

Mechanism of ActionLead Chelating Activity

Suppliers and Packaging for NDA: 021749

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pentetate calcium trisodium
SOLUTION;INHALATION, INTRAVENOUS 021749 NDA hameln pharma plus gmbh 70651-001 70651-001-03 10 AMPULE in 1 PACKAGE (70651-001-03) > 5 mL in 1 AMPULE

Summary 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1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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