Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219189
Company: IONETIX

Products on ANDA 219189

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALLIUM GA-68 GOZETOTIDE	GALLIUM GA-68 GOZETOTIDE	0.5-5mCi/mL	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219189

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219189

GALLIUM GA-68 GOZETOTIDE

SOLUTION;INTRAVENOUS; 0.5-5mCi/mL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GALLIUM GA 68 GOZETOTIDE	GALLIUM GA-68 GOZETOTIDE	0.5-5mCi/mL	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	212643	UNIV OF CA SAN FRAN
GALLIUM GA-68 GOZETOTIDE	GALLIUM GA-68 GOZETOTIDE	0.5-5mCi/mL	SOLUTION;INTRAVENOUS	Prescription	No	AP	219189	IONETIX