Details for New Drug Application (NDA): 019829

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NDA 019829 describes CERETEC, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from two suppliers. Additional details are available on the CERETEC profile page.

The generic ingredient in CERETEC is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.

Summary for 019829

Tradename:	CERETEC
Applicant:	Ge Healthcare
Ingredient:	technetium tc-99m exametazime kit
Patents:	0

Pharmacology for NDA: 019829

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 019829

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829	NDA	Medi-Physics Inc. dba GE Healthcare.	17156-022	17156-022-05	5 VIAL in 1 TRAY (17156-022-05) / 5 mL in 1 VIAL
CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829	NDA	Medi-Physics, Inc. dba GE Healthcare	17156-025	17156-025-05	1 KIT in 1 CARTON (17156-025-05) * 5 mL in 1 VIAL, GLASS (17156-022-05) * 2.5 mL in 1 VIAL, GLASS (17156-027-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	N/A
Approval Date:	Dec 30, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 019829

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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