Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219007
Company: TEVA NEUROSCIENCE INC
Company: TEVA NEUROSCIENCE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WELTRUZA | OLANZAPINE | 318MG | SUSPENSION, EXTENDED RELEASE;INJECTABLE | Prescription | None | No | No |
| WELTRUZA | OLANZAPINE | 425MG | SUSPENSION, EXTENDED RELEASE;INJECTABLE | Prescription | None | No | No |
| WELTRUZA | OLANZAPINE | 531MG | SUSPENSION, EXTENDED RELEASE;INJECTABLE | 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 |
|---|---|---|---|---|---|---|---|
| 10/08/2026 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219007Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219007Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/08/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219007Orig1s000lbl.pdf |