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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 019414

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NDA 019414 describes CARDIOGEN-82, 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 CARDIOGEN-82 profile page.

The generic ingredient in CARDIOGEN-82 is rubidium chloride rb-82. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rubidium chloride rb-82 profile page.

Summary for 019414

Tradename:	CARDIOGEN-82
Applicant:	Bracco
Ingredient:	rubidium chloride rb-82
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019414

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 019414

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414	NDA	Bracco Diagnostics Inc	0270-0091	0270-0091-01	1 INJECTION, SOLUTION in 1 PACKAGE (0270-0091-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	N/A
Approval Date:	Dec 29, 1989	TE:		RLD:	No

Expired US Patents for NDA 019414

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414-001	Dec 29, 1989	⤷ Try a Trial	⤷ Try a Trial
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414-001	Dec 29, 1989	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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