FDA Approval for RINVOQ issued to ABBVIE INC
$ABBV
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 218347
Company: ABBVIE INC
Company: ABBVIE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RINVOQ | UPADACITINIB | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| RINVOQ | UPADACITINIB | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| RINVOQ | UPADACITINIB | 45MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| RINVOQ LQ | UPADACITINIB | 1MG/ML | SOLUTION;ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2024 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218347s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/26/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218347s000lbl.pdf |