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Generated: April 21, 2019

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Details for New Drug Application (NDA): 020570

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NDA 020570 describes QUADRAMET, which is a drug marketed by Lantheus Medical and is included in one NDA. It is available from one supplier. Additional details are available on the QUADRAMET profile page.

The generic ingredient in QUADRAMET is samarium sm-153 lexidronam pentasodium. One supplier is listed for this compound. Additional details are available on the samarium sm-153 lexidronam pentasodium profile page.
Summary for 020570
Applicant:Lantheus Medical
Ingredient:samarium sm-153 lexidronam pentasodium
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUADRAMET samarium sm-153 lexidronam pentasodium INJECTABLE;INJECTION 020570 NDA Lantheus Medical Imaging, Inc. 11994-016 11994-016-01 3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50mCi/ML
Approval Date:Mar 28, 1997TE:RLD:Yes

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