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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019044
Company: GE HEALTHCARE

Products on NDA 019044

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	1mCi/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019044

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/1985	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/019044Orig1s000lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2022	SUPPL-25	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019044Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019044Orig1s025ltr.pdf
07/07/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/08/2013	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/19/2002	SUPPL-18	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19044slr018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019044_s018_indium in-111 oxyquinoline.pdf
08/30/1999	SUPPL-17	Manufacturing (CMC)-Formulation	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019044Orig1s017.pdf
08/02/2000	SUPPL-16	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019044_s016_indium in-111 oxyquinoline.pdf
10/16/1997	SUPPL-15	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/019044Orig1s015.pdf
08/11/1995	SUPPL-13	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s010_s011_s013_indium in-111 oxyquinoline.pdf
01/13/1995	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/11/1995	SUPPL-11	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s010_s011_s013_indium in-111 oxyquinoline.pdf
08/11/1995	SUPPL-10	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s010_s011_s013_indium in-111 oxyquinoline.pdf
08/27/1990	SUPPL-9	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s009_indium in-111 oxyquinoline.pdf
08/08/1990	SUPPL-8	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s008_indium in-111 oxyquinoline.pdf
08/08/1990	SUPPL-6	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s006-_indium-in-111-oxyquinoline.pdf
04/11/1989	SUPPL-5	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s005_indium-in-111 oxyquinoline.pdf
06/08/1987	SUPPL-3	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s003_indium in 111 oxyquinoline.pdf
12/12/1989	SUPPL-2	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019044_s002_indium in-111 oxyquinoline.pdf

Labels for NDA 019044

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2022	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019044Orig1s025lbl.pdf
12/12/2022	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019044Orig1s025lbl.pdf
12/24/1985	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/019044Orig1s000lbl.pdf

Therapeutic Equivalents for NDA 019044

INDIUM IN 111 OXYQUINOLINE

INJECTABLE;INJECTION; 1mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	1mCi/ML	INJECTABLE;INJECTION	Prescription	No	AP	202586	BWXT ITG
INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	1mCi/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019044	GE HEALTHCARE

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