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Generated: January 21, 2019

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Details for New Drug Application (NDA): 019818

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NDA 019818 describes ADAGEN, which is a drug marketed by Leadiant Biosci Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ADAGEN profile page.

The generic ingredient in ADAGEN is pegademase bovine. One supplier is listed for this compound. Additional details are available on the pegademase bovine profile page.
Summary for 019818
Applicant:Leadiant Biosci Inc
Ingredient:pegademase bovine
Pharmacology for NDA: 019818
Suppliers and Packaging for NDA: 019818
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAGEN pegademase bovine INJECTABLE;INJECTION 019818 NDA Leadiant Biosciences, Inc. 57665-001 57665-001-01 4 VIAL, SINGLE-USE in 1 BOX (57665-001-01) > 1.5 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250 UNITS/ML
Approval Date:Mar 21, 1990TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

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