Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207098
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ILOPERIDONE | ILOPERIDONE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| ILOPERIDONE | ILOPERIDONE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| ILOPERIDONE | ILOPERIDONE | 4MG | TABLET;ORAL | Discontinued | None | No | No |
| ILOPERIDONE | ILOPERIDONE | 6MG | TABLET;ORAL | Discontinued | None | No | No |
| ILOPERIDONE | ILOPERIDONE | 8MG | TABLET;ORAL | Discontinued | None | No | No |
| ILOPERIDONE | ILOPERIDONE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| ILOPERIDONE | ILOPERIDONE | 12MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/22/2019 | ORIG-1 | Approval | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/207098Orig1s000.pdf |