Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209905
Company: AZURITY
Company: AZURITY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EVEKEO ODT | AMPHETAMINE SULFATE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
EVEKEO ODT | AMPHETAMINE SULFATE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
EVEKEO ODT | AMPHETAMINE SULFATE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
EVEKEO ODT | AMPHETAMINE SULFATE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
EVEKEO ODT | AMPHETAMINE SULFATE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/30/2019 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209905s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209905Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209905Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/13/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209905s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209905Orig1s004ltr.pdf | |
09/30/2022 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209905Orig1s003ltr.pdf | |
02/25/2022 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209905Orig1s002_Corrected_ltr.pdf | |
04/16/2021 | SUPPL-1 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209905Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209905Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/13/2023 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209905s004lbl.pdf | |
10/13/2023 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209905s004lbl.pdf | |
09/30/2022 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s003lbl.pdf | |
02/25/2022 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s002lbl.pdf | |
04/16/2021 | SUPPL-1 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209905Orig1s001lbl.pdf | |
01/30/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209905s000lbl.pdf |