Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020923
Company: LIEBEL-FLARSHEIM
Company: LIEBEL-FLARSHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OPTIRAY 240 | IOVERSOL | 51% | INJECTABLE;INJECTION | Discontinued | None | No | No |
OPTIRAY 300 | IOVERSOL | 64% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
OPTIRAY 320 | IOVERSOL | 68% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
OPTIRAY 350 | IOVERSOL | 74% | 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 |
---|---|---|---|---|---|---|---|
05/29/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20923lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20923ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20923_Optiray.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/25/2023 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019710s067,020923s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019710Orig1s067;020923Orig1s030ltr.pdf | |
02/18/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710s065,020923s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019710Orig1s065; 020923Orig1s028ltr.pdf | |
11/18/2020 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020923Orig1s026ltr.pdf | |
11/18/2020 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020923Orig1s025ltr.pdf | |
12/12/2017 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020923Orig1s021ltr.pdf | |
04/05/2017 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s055,020923Orig1s020ltr.pdf | |
04/26/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s054,020923Orig1s019ltr.pdf | |
07/06/2015 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923Orig1s018ltr.pdf | |
12/19/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/12/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019710Orig1s039,020923Orig1s009ltr.pdf | |
08/08/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
09/12/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/14/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/13/1999 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/25/2023 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019710s067,020923s030lbl.pdf | |
02/18/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710s065,020923s028lbl.pdf | |
11/18/2020 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s026lbl.pdf | |
11/18/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s026lbl.pdf | |
11/18/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s025lbl.pdf | |
12/12/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s021lbl.pdf | |
04/26/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf | |
04/05/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s020lbl.pdf | |
08/12/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf | |
07/06/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf | |
05/29/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20923lbl.pdf |