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 | Discontinued | None | Yes | No |
| OPTIRAY 320 | IOVERSOL | 68% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| OPTIRAY 350 | IOVERSOL | 74% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s026lbl.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-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 |