Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213932
Company: SUN PHARM
Company: SUN PHARM
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 4.5MG 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 |
---|---|---|---|---|---|---|---|
09/30/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213932Orig1s000TAltr.pdf |