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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 NDA: 019414

Formulation / Manufacturing:see details

Pharmacology for NDA: 019414

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 019414

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Dec 29, 1989TE:RLD:No

Expired Orange Book Patents for NDA: 019414

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
rubidium chloride rb-82
INJECTABLE;INJECTION019414-001Dec 29, 19894,400,358► Subscribe
rubidium chloride rb-82
INJECTABLE;INJECTION019414-001Dec 29, 19894,562,829► Subscribe
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