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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218845

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NDA 218845 describes GALLIUM GA 68 EDOTREOTIDE, which is a drug marketed by Methodist and Uihc Pet Imaging and is included in two NDAs. It is available from one supplier. Additional details are available on the GALLIUM GA 68 EDOTREOTIDE profile page.

The generic ingredient in GALLIUM GA 68 EDOTREOTIDE is gallium ga-68 edotreotide. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium ga-68 edotreotide profile page.

Summary for 218845

Tradename:	GALLIUM GA 68 EDOTREOTIDE
Applicant:	Methodist
Ingredient:	gallium ga-68 edotreotide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.5-4mCi/ML
Approval Date:	Oct 10, 2025	TE:	AP	RLD:	No

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