Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091079
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Discontinued | None | No | No |
OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | 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 |
---|---|---|---|---|---|---|---|
04/24/2017 | ORIG-1 | Approval |
Label is not available on this site. |