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Generated: November 21, 2018

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Details for New Drug Application (NDA): 018511

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NDA 018511 describes DTPA, which is a drug marketed by Jubilant Draximage and is included in one NDA. It is available from one supplier. Additional details are available on the DTPA profile page.

The generic ingredient in DTPA is technetium tc-99m pentetate kit. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m pentetate kit profile page.
Summary for 018511
Tradename:DTPA
Applicant:Jubilant Draximage
Ingredient:technetium tc-99m pentetate kit
Patents:0
Pharmacology for NDA: 018511
Mechanism of ActionLead Chelating Activity
Suppliers and Packaging for NDA: 018511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DTPA technetium tc-99m pentetate kit INJECTABLE;INJECTION 018511 NDA Jubilant DraxImage Inc. 65174-288 65174-288-05 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-05)
DTPA technetium tc-99m pentetate kit INJECTABLE;INJECTION 018511 NDA Jubilant DraxImage Inc. 65174-288 65174-288-30 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Dec 29, 1989TE:RLD:Yes

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