Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216137
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALBENAZINE TOSYLATE | VALBENAZINE TOSYLATE | EQ 40MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| VALBENAZINE TOSYLATE | VALBENAZINE TOSYLATE | EQ 60MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| VALBENAZINE TOSYLATE | VALBENAZINE TOSYLATE | EQ 80MG BASE | CAPSULE;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 08/07/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216137Orig1s000TAltr.pdf |