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Details for New Drug Application (NDA): 018058

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NDA 018058 describes GALLIUM CITRATE GA 67, which is a drug marketed by Ge Healthcare, Mallinkrodt Nuclear, and Lantheus Medcl, and is included in three NDAs. It is available from three 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 fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the gallium citrate ga-67 profile page.

Summary for NDA: 018058

Mallinkrodt Nuclear
gallium citrate ga-67

Suppliers and Packaging for NDA: 018058

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
gallium citrate ga-67
INJECTABLE;INJECTION 018058 NDA Mallinckrodt Inc. 0019-9180 0019-9180-06 1 VIAL in 1 CAN (0019-9180-06) > 3.3 mL in 1 VIAL
gallium citrate ga-67
INJECTABLE;INJECTION 018058 NDA Mallinckrodt Inc. 0019-9180 0019-9180-12 1 VIAL in 1 CAN (0019-9180-12) > 6.6 mL in 1 VIAL

Summary 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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