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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Healthtrust
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018035

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NDA 018035 describes DRAXIMAGE MDP-25, 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 DRAXIMAGE MDP-25 profile page.

The generic ingredient in DRAXIMAGE MDP-25 is technetium tc-99m medronate. 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 medronate profile page.
Summary for 018035
Tradename:DRAXIMAGE MDP-25
Applicant:Jubilant Draximage
Ingredient:technetium tc-99m medronate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018035
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DRAXIMAGE MDP-10 technetium tc-99m medronate INJECTABLE;INJECTION 018035 NDA Jubilant DraxImage Inc 65174-660 65174-660-30 30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (65174-660-30)
DRAXIMAGE MDP-25 technetium tc-99m medronate INJECTABLE;INJECTION 018035 NDA Jubilant DraxImage Inc 65174-660 65174-660-30 30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (65174-660-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Feb 27, 2004TE:RLD:Yes

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Dow
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