New Drug Application (NDA): 205489
Company: NEOS THERAPS INC
Company: NEOS THERAPS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COTEMPLA XR-ODT | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| COTEMPLA XR-ODT | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| COTEMPLA XR-ODT | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/19/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205489Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205489Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/25/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/19/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf |