Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208700
Company: AAA USA INC
Company: AAA USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUTATHERA | LUTETIUM LU 177 DOTATATE | 10mCi/ML | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
01/26/2018 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208700Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208700Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2024 | SUPPL-31 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208700s031lbl.pdf | |
03/07/2023 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208700s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208700Orig1s026ltr.pdf | |
06/13/2022 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700s019s023lbl.pdf | |
06/06/2022 | SUPPL-20 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700Orig1s020ltr.pdf |
06/13/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700Orig1s019,s023ltr.pdf | |
05/28/2020 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208700Orig1s010ltr.pdf |
05/29/2020 | SUPPL-1 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208700s010lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/23/2024 | SUPPL-31 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208700s031lbl.pdf | |
03/07/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208700s026lbl.pdf | |
06/13/2022 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf | |
06/13/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf | |
05/29/2020 | SUPPL-1 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208700s010lbl.pdf | |
01/26/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf |