Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208462
Company: MILLENNIUM PHARMS
Company: MILLENNIUM PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NINLARO | IXAZOMIB CITRATE | EQ 2.3MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| NINLARO | IXAZOMIB CITRATE | EQ 3MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| NINLARO | IXAZOMIB CITRATE | EQ 4MG BASE | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/20/2015 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208462Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208462Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208462Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/10/2020 | SUPPL-8 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208462Orig1s007, s008ltr.pdf | |
| 09/10/2020 | SUPPL-7 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208462Orig1s007, s008ltr.pdf | |
| 02/21/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208462Orig1s006ltr.pdf | |
| 11/23/2016 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208462s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208462Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/10/2020 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf | |
| 09/10/2020 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf | |
| 02/21/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462s006lbl.pdf | |
| 11/23/2016 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208462s001lbl.pdf | |
| 11/20/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English