Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090398
Company: MATRIX LABS LTD
Company: MATRIX LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | 5MG/20MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | 5MG/40MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | 10MG/20MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | 10MG/40MG | TABLET; ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/07/2011 | ORIG-1 | Tentative Approval |
Label is not available on this site. |