Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217677
Company: SPRINGWORKS
Company: SPRINGWORKS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OGSIVEO | NIROGACESTAT HYDROBROMIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
OGSIVEO | NIROGACESTAT HYDROBROMIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
OGSIVEO | NIROGACESTAT HYDROBROMIDE | EQ 150MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
11/27/2023 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217677Orig1s000_Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217677Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217677Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/04/2024 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217677Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217677Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/04/2024 | SUPPL-1 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217677Orig1s001lbl.pdf | |
11/27/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217677Orig1s000_Corrected_lbl.pdf |