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Generated: January 23, 2019

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Details for New Drug Application (NDA): 019981

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NDA 019981 describes ULTRATAG, which is a drug marketed by Mallinkrodt Nuclear and is included in one NDA. It is available from one supplier. Additional details are available on the ULTRATAG profile page.

The generic ingredient in ULTRATAG is technetium tc-99m red blood cell 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 red blood cell kit profile page.
Summary for 019981
Applicant:Mallinkrodt Nuclear
Ingredient:technetium tc-99m red blood cell kit
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019981
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRATAG technetium tc-99m red blood cell kit INJECTABLE;INJECTION 019981 NDA Curium US LLC 69945-068 69945-068-20 5 CELLO PACK in 1 BOX (69945-068-20) > 1 KIT in 1 CELLO PACK * .6 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASS * 9.5 mg in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Jun 10, 1991TE:RLD:Yes

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