Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204441
Company: OTSUKA
Company: OTSUKA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
JYNARQUE | TOLVAPTAN | 15MG | TABLET;ORAL | Prescription | None | Yes | No |
JYNARQUE | TOLVAPTAN | 30MG | TABLET;ORAL | Prescription | None | Yes | No |
JYNARQUE | TOLVAPTAN | 45MG | TABLET;ORAL | Prescription | None | Yes | Yes |
JYNARQUE | TOLVAPTAN | 60MG | TABLET;ORAL | Prescription | None | Yes | No |
JYNARQUE | TOLVAPTAN | 90MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/23/2018 | ORIG-1 | Approval | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204441Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/29/2023 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204441Orig1s010ltr.pdf |
11/25/2020 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204441Orig1s009ltr.pdf |
10/19/2020 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204441s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204441Orig1s008ltr.pdf | |
12/03/2019 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204441Orig1s007ltr.pdf |
12/01/2018 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441s002ltr.pdf | |
07/30/2018 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s001Ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/19/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204441s008lbl.pdf | |
12/01/2018 | SUPPL-2 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441s002lbl.pdf | |
04/23/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf |