Details for New Drug Application (NDA): 018963

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NDA 018963 describes CHOLETEC, which is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. Additional details are available on the CHOLETEC profile page.

The generic ingredient in CHOLETEC is technetium tc-99m mebrofenin 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 mebrofenin kit profile page.

Summary for 018963

Tradename:	CHOLETEC
Applicant:	Bracco
Ingredient:	technetium tc-99m mebrofenin kit
Patents:	0

Suppliers and Packaging for NDA: 018963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963	NDA	Bracco Diagnostics Inc	0270-0083	0270-0083-20	10 VIAL in 1 CARTON (0270-0083-20) / 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:	Jan 21, 1987	TE:	AP	RLD:	Yes

Expired US Patents for NDA 018963

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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