Details for New Drug Application (NDA): 018321

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NDA 018321 describes TECHNESCAN, which is a drug marketed by Curium and Draximage and is included in five 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	N/A
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018321

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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	⤷ Sign Up	⤷ Sign Up
Curium	TECHNESCAN	technetium tc-99m oxidronate kit	INJECTABLE;INJECTION	018321-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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