Details for New Drug Application (NDA): 079157

NDA 079157 describes TECHNETIUM TC 99M SESTAMIBI, which is a drug marketed by Cardinal Health 414, Curium, Jubilant Draximage, and Sun Pharm Inds Inc, and is included in four NDAs. It is available from four suppliers. Additional details are available on the TECHNETIUM TC 99M SESTAMIBI profile page.

The generic ingredient in TECHNETIUM TC 99M SESTAMIBI is technetium tc-99m sestamibi kit. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the technetium tc-99m sestamibi kit profile page.

Summary for 079157

Tradename:	TECHNETIUM TC 99M SESTAMIBI
Applicant:	Sun Pharm Inds Inc
Ingredient:	technetium tc-99m sestamibi kit
Patents:	0

Pharmacology for NDA: 079157

Mechanism of Action

Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 079157

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TECHNETIUM TC 99M SESTAMIBI	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	079157	ANDA	Sun Pharmaceutical Industries, Inc.	45567-0555	45567-0555-1	5 VIAL in 1 CARTON (45567-0555-1) / 10 mL in 1 VIAL
TECHNETIUM TC 99M SESTAMIBI	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	079157	ANDA	Sun Pharmaceutical Industries, Inc.	45567-0555	45567-0555-2	30 VIAL in 1 CARTON (45567-0555-2) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10-30mCi
Approval Date:	Jul 10, 2009	TE:	AP	RLD:	No

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