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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 two suppliers. Additional details are available on the QUADRAMET profile page.

The generic ingredient in QUADRAMET is samarium sm-153 lexidronam pentasodium. Two suppliers are listed for this compound. Additional details are available on the samarium sm-153 lexidronam pentasodium profile page.

Summary for NDA: 020570

Tradename:
QUADRAMET
Applicant:
Lantheus Medical
Ingredient:
samarium sm-153 lexidronam pentasodium
Patents:0
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)
QUADRAMET
samarium sm-153 lexidronam pentasodium
INJECTABLE;INJECTION 020570 NDA Jazz Pharmaceuticals, Inc. 57902-860 57902-860-03 3 mL in 1 VIAL, SINGLE-DOSE (57902-860-03)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020570

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lantheus Medical
QUADRAMET
samarium sm-153 lexidronam pentasodium
INJECTABLE;INJECTION020570-001Mar 28, 19974,898,724► subscribe
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