Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213718
Company: AJANTA PHARMA LTD
Company: AJANTA PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BREXPIPRAZOLE | BREXPIPRAZOLE | 0.25MG | TABLET;ORAL | Discontinued | None | No | No |
| BREXPIPRAZOLE | BREXPIPRAZOLE | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| BREXPIPRAZOLE | BREXPIPRAZOLE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| BREXPIPRAZOLE | BREXPIPRAZOLE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| BREXPIPRAZOLE | BREXPIPRAZOLE | 3MG | TABLET;ORAL | Discontinued | None | No | No |
| BREXPIPRAZOLE | BREXPIPRAZOLE | 4MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/03/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213718Orig1s000TA_ltr.pdf |