Last Updated: July 28, 2026

Details for New Drug Application (NDA): 216410

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NDA 216410 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 216410

Tradename:	GALLIUM GA 68 GOZETOTIDE
Applicant:	Radiomedix
Ingredient:	gallium ga-68 gozetotide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.5-5mCi/ML
Approval Date:	Jun 8, 2026	TE:	AP	RLD:	No

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