Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215110
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAVYRET | GLECAPREVIR; PIBRENTASVIR | 50MG;20MG/PACKET | PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 06/10/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s000; 209394Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215110Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2023 | SUPPL-3 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209394Orig1s016;215110Orig1s003ltr.pdf | |
| 09/28/2021 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s001;209394Orig1s014ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/25/2023 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf | |
| 09/28/2021 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf | |
| 09/28/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf | |
| 06/10/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf |