Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078825
Company: MYLAN PHARMA
Company: MYLAN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | 2MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | 4MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | 8MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/02/2008 | ORIG-1 | Tentative Approval |
Label is not available on this site. |