Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078276
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 10/26/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078276Orig1s000ltr.pdf |
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