Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210108
Company: UNICHEM LABS LTD
Company: UNICHEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APIXABAN | APIXABAN | 0.5MG | TABLET; FILM COATED | None (Tentative Approval) | None | No | No |
| APIXABAN | APIXABAN | 1.5MG | TABLET; FILM COATED | None (Tentative Approval) | None | No | No |
| APIXABAN | APIXABAN | 2.0MG | TABLET; FILM COATED | None (Tentative Approval) | None | No | No |
| APIXABAN | APIXABAN | 5MG | TABLET; FILM COATED | None (Tentative Approval) | None | No | No |
| APIXABAN | APIXABAN | 2.5MG | TABLET; FILM COATED | 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 |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ORIG-1 | Tentative Approval | STANDARD |
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