Last Updated: August 3, 2026

Details for New Drug Application (NDA): 212642

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NDA 212642 describes GALLIUM GA 68 GOZETOTIDE, which is a drug marketed by Radiomedix, Univ Ca Los Angeles, and Univ Of Ca San Fran, and is included in three NDAs. It is available from two suppliers. Additional details are available on the GALLIUM GA 68 GOZETOTIDE profile page.

The generic ingredient in GALLIUM GA 68 GOZETOTIDE is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.

Summary for 212642

Tradename:	GALLIUM GA 68 GOZETOTIDE
Applicant:	Univ Ca Los Angeles
Ingredient:	gallium ga-68 gozetotide
Patents:	0

Pharmacology for NDA: 212642

Mechanism of Action	Positron Emitting Activity

Suppliers and Packaging for NDA: 212642

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212642	NDA	UCLA Biomedical Cyclotron	76394-2642	76394-2642-3	12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.5-5mCi/mL
Approval Date:	Dec 1, 2020	TE:		RLD:	Yes

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