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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018467

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NDA 018467 describes HEPATOLITE, which is a drug marketed by Pharmalucence and is included in one NDA. It is available from one supplier. Additional details are available on the HEPATOLITE profile page.

The generic ingredient in HEPATOLITE is technetium tc-99m disofenin kit. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m disofenin kit profile page.
Summary for 018467
Ingredient:technetium tc-99m disofenin kit
Pharmacology for NDA: 018467
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 018467
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPATOLITE technetium tc-99m disofenin kit INJECTABLE;INJECTION 018467 NDA Pharmalucence, Inc. 45567-0475 45567-0475-1 5 VIAL in 1 KIT (45567-0475-1) > 10 mL in 1 VIAL
HEPATOLITE technetium tc-99m disofenin kit INJECTABLE;INJECTION 018467 NDA Pharmalucence, Inc. 45567-0475 45567-0475-2 30 VIAL in 1 KIT (45567-0475-2) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Mar 16, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Chinese Patent Office

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