Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
03/12/2024 | SUPPL-16 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205489Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205489Orig1s016ltr.pdf | |
10/13/2023 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205489s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205489Orig1s012ltr.pdf | |
06/25/2021 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205489Orig1s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/12/2024 | SUPPL-16 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205489Orig1s016lbl.pdf |
10/13/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205489s012lbl.pdf | |
06/25/2021 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf | |
06/19/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf |