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Generated: February 20, 2019

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Details for New Drug Application (NDA): 018310

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NDA 018310 describes LYMPHAZURIN, which is a drug marketed by Covidien and is included in one NDA. It is available from one supplier. Additional details are available on the LYMPHAZURIN profile page.

The generic ingredient in LYMPHAZURIN is isosulfan blue. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.
Summary for 018310
Ingredient:isosulfan blue
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018310
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYMPHAZURIN isosulfan blue INJECTABLE;INJECTION 018310 NDA UNITED STATES SURGICAL CORPORATION 63261-250 63261-250-21 5 mL in 1 VIAL, SINGLE-USE (63261-250-21)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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