Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009190
Company: GUERBET
Company: GUERBET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIPIODOL | ETHIODIZED OIL | EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML) | OIL;INTRALYMPHATIC, INTRAUTERINE | 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 |
---|---|---|---|---|---|---|---|
03/31/1954 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/05/2023 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009190s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/009190Orig1s032ltr.pdf | |
06/10/2020 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009190Orig1s029, s031ltr.pdf | |
06/10/2020 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009190Orig1s029, s031ltr.pdf | |
09/28/2018 | SUPPL-27 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/04/2014 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s024ltr.pdf | |
01/23/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/21/2014 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s021ltr.pdf | |
09/10/1985 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
11/14/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/14/1979 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/07/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/05/2023 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009190s032lbl.pdf | |
06/10/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf | |
06/10/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf | |
04/04/2014 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf | |
03/21/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf |