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Generated: May 25, 2019

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Details for New Drug Application (NDA): 018321

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NDA 018321 describes TECHNESCAN, which is a drug marketed by Curium, Draximage, and Mallinckrodt, and is included in six NDAs. It is available from one supplier. Additional details are available on the TECHNESCAN profile page.

The generic ingredient in TECHNESCAN is technetium tc-99m pyrophosphate kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m pyrophosphate kit profile page.
Summary for 018321
Tradename:TECHNESCAN
Applicant:Curium
Ingredient:technetium tc-99m oxidronate kit
Patents:0
Suppliers and Packaging for NDA: 018321
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TECHNESCAN technetium tc-99m oxidronate kit INJECTABLE;INJECTION 018321 NDA Curium US LLC 69945-091 69945-091-20 5 VIAL in 1 CELLO PACK (69945-091-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
TECHNESCAN technetium tc-99m oxidronate kit INJECTABLE;INJECTION 018321 NDA Curium US LLC 69945-091 69945-091-40 30 VIAL in 1 CARTON (69945-091-40) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 018321

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Curium TECHNESCAN technetium tc-99m oxidronate kit INJECTABLE;INJECTION 018321-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Curium TECHNESCAN technetium tc-99m oxidronate kit INJECTABLE;INJECTION 018321-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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