Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209885
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AUSTEDO | DEUTETRABENAZINE | 6MG | TABLET;ORAL | Prescription | None | No | No |
| AUSTEDO | DEUTETRABENAZINE | 9MG | TABLET;ORAL | Prescription | None | No | No |
| AUSTEDO | DEUTETRABENAZINE | 12MG | TABLET;ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2017 | ORIG-1 | Approval | PRIORITY |
Label (PDF)
Letter (PDF) Review |
See NDA 208082 for the most up-to-date labeling | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209885lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209885Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/30/2017 | ORIG-1 | Approval | Label (PDF) | See NDA 208082 for the most up-to-date labeling | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209885lbl.pdf |