Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076094
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERGOLIDE MESYLATE | PERGOLIDE MESYLATE | EQ 0.05MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| PERGOLIDE MESYLATE | PERGOLIDE MESYLATE | EQ 0.25MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| PERGOLIDE MESYLATE | PERGOLIDE MESYLATE | EQ 1MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 09/04/2003 | ORIG-1 | Approval |
Label is not available on this site. |