Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019044
Company: GE HEALTHCARE
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 None Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/24/1985 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/019044Orig1s000lbl.pdf

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