Drugs@FDA: FDA-Approved Drugs
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 | AP | 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 |
---|---|---|---|---|---|
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 |
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 |
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 |