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Generated: November 17, 2018

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Details for New Drug Application (NDA): 017478

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NDA 017478 describes GALLIUM CITRATE GA 67, which is a drug marketed by Ge Healthcare, Lantheus Medcl, and Mallinkrodt Nuclear, and is included in three NDAs. It is available from two suppliers. Additional details are available on the GALLIUM CITRATE GA 67 profile page.

The generic ingredient in GALLIUM CITRATE GA 67 is gallium citrate ga-67. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the gallium citrate ga-67 profile page.
Summary for 017478
Tradename:GALLIUM CITRATE GA 67
Applicant:Lantheus Medcl
Ingredient:gallium citrate ga-67
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017478
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALLIUM CITRATE GA 67 gallium citrate ga-67 INJECTABLE;INJECTION 017478 NDA Lantheus Medical Imaging, Inc. 11994-121 11994-121-06 3.3 mL in 1 VIAL (11994-121-06)
GALLIUM CITRATE GA 67 gallium citrate ga-67 INJECTABLE;INJECTION 017478 NDA Lantheus Medical Imaging, Inc. 11994-121 11994-121-08 4.4 mL in 1 VIAL (11994-121-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2mCi/ML
Approval Date:Approved Prior to Jan 1, 1982TE:BSRLD:No

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