Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211765
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
UBRELVY | UBROGEPANT | 50MG | TABLET;ORAL | Prescription | None | Yes | No |
UBRELVY | UBROGEPANT | 100MG | 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 |
---|---|---|---|---|---|---|---|
12/23/2019 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211765s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211765Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211765Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/17/2023 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211765s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211765Orig1s007ltr.pdf | |
03/03/2021 | SUPPL-2 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211765Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/17/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211765s007lbl.pdf | |
12/23/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211765s000lbl.pdf |