Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213982
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARIPRAZINE HYDROCHLORIDE | CARIPRAZINE HYDROCHLORIDE | EQ 1.5MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| CARIPRAZINE HYDROCHLORIDE | CARIPRAZINE HYDROCHLORIDE | EQ 3MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| CARIPRAZINE HYDROCHLORIDE | CARIPRAZINE HYDROCHLORIDE | EQ 6MG 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 |
|---|---|---|---|---|---|---|---|
| 12/16/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |