Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210526
Company: TRIS PHARMA INC
Company: TRIS PHARMA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DYANAVEL XR 10 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 8MG;EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
DYANAVEL XR 15 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 12MG;EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
DYANAVEL XR 20 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 16MG;EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
DYANAVEL XR 5 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 4MG;EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
11/04/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210526s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210526Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/210526Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/13/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208147Orig1s016; 210526Orig1s008ltr.pdf | |
02/25/2022 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147s013,210526s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208147Orig1s013; 210526Orig1s003correctedltr.pdf | |
10/14/2022 | SUPPL-2 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210526Orig1s002ltr.pdf |
06/01/2022 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s012,210526Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208147Orig1s012; 210526Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/13/2023 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf | |
10/13/2023 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf | |
06/01/2022 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s012,210526Orig1s001lbl.pdf | |
02/25/2022 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147s013,210526s003lbl.pdf | |
11/04/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210526s000lbl.pdf |