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Generated: November 20, 2018

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Details for New Drug Application (NDA): 017858

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NDA 017858 describes AN-SULFUR COLLOID, 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 AN-SULFUR COLLOID profile page.

The generic ingredient in AN-SULFUR COLLOID is technetium tc-99m sulfur colloid 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 sulfur colloid kit profile page.
Summary for 017858
Tradename:AN-SULFUR COLLOID
Applicant:Pharmalucence
Ingredient:technetium tc-99m sulfur colloid kit
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AN-SULFUR COLLOID technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017858 NDA Pharmalucence Inc. 45567-0030 45567-0030-1 1 KIT in 1 PACKAGE (45567-0030-1) * 3 mL in 1 VIAL * 3 mL in 1 VIAL * 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORALStrengthN/A
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 13, 2019
Regulatory Exclusivity Use:LOCALIZATION OF LYMPH NODES DRAINING A PRIMARY TUMOR IN PATIENTS WITH MELANOMA WHEN USED WITH A HAND-HELD GAMMA COUNTER

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