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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218845
Company: METHODIST

Products on ANDA 218845

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALLIUM GA 68 EDOTREOTIDE	GALLIUM GA-68 EDOTREOTIDE	0.5-4mCi/ML	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218845

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218845

GALLIUM GA 68 EDOTREOTIDE

SOLUTION;INTRAVENOUS; 0.5-4mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GALLIUM GA 68 EDOTREOTIDE	GALLIUM GA-68 EDOTREOTIDE	0.5-4mCi/ML	SOLUTION;INTRAVENOUS	Prescription	No	AP	218845	METHODIST
GALLIUM GA 68 EDOTREOTIDE	GALLIUM GA-68 EDOTREOTIDE	0.5-4mCi/ML	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	210828	UIHC PET IMAGING

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