Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215401
Company: NOVEN PHARMS INC
Company: NOVEN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XELSTRYM | DEXTROAMPHETAMINE | 4.5MG/9HR | SYSTEM;TRANSDERMAL | Prescription | None | Yes | No |
| XELSTRYM | DEXTROAMPHETAMINE | 9MG/9HR | SYSTEM;TRANSDERMAL | Prescription | None | Yes | No |
| XELSTRYM | DEXTROAMPHETAMINE | 13.5MG/9HR | SYSTEM;TRANSDERMAL | Prescription | None | Yes | No |
| XELSTRYM | DEXTROAMPHETAMINE | 18MG/9HR | SYSTEM;TRANSDERMAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/22/2022 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215401Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215401Orig1s000TOC.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 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215401s008lbl.pdf | |
| 08/16/2022 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215401Orig1s001ltr.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/2023/215401s008lbl.pdf | |
| 08/16/2022 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s001lbl.pdf | |
| 03/22/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s000lbl.pdf |