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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 NDA: 018963

technetium tc-99m mebrofenin kit

Suppliers and Packaging for NDA: 018963

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Jan 21, 1987TE:APRLD:Yes

Expired Orange Book Patents for NDA: 018963

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
technetium tc-99m mebrofenin kit
INJECTABLE;INJECTION018963-001Jan 21, 19874,418,208<disabled>
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