FDA Approval for FINTEPLA issued to ZOGENIX INC
$ZGNX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 212102
Company: ZOGENIX INC
Company: ZOGENIX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FINTEPLA | FENFLURAMINE HYDROCHLORIDE | EQ 2.2MG BASE/ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 06/25/2020 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212102s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212102Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212102Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/30/2023 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
||
| 01/03/2023 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212102Orig1s006ltr.pdf | |
| 06/15/2022 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212102Orig1s005ltr.pdf | |
| 03/25/2022 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212102Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/03/2023 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212102s006lbl.pdf | |
| 06/15/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s005lbl.pdf | |
| 03/25/2022 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s003lbl.pdf | |
| 06/25/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212102s000lbl.pdf |