Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207231
Company: INVENTIA
Company: INVENTIA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/28/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207231Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/207231Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/11/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |