Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219421
Company: ALKEM LABORATORIES LIMITED
Company: ALKEM LABORATORIES LIMITED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEMPEDOIC ACID AND EZETIMIBE | BEMPEDOIC ACID, EZETIMIBE | 10MG | TABLET | None (Tentative Approval) | None | No | No |
| BEMPEDOIC ACID AND EZETIMIBE | BEMPEDOIC ACID, EZETIMIBE | 180MG | TABLET | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 10/23/2025 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219421Orig1s000TAltr.pdf |