Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078240
Company: PLIVA HRVATSKA DOO
Company: PLIVA HRVATSKA DOO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Discontinued | None | No | No |
CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Discontinued | None | No | No |
CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Discontinued | None | No | No |
CARVEDILOL | CARVEDILOL | 25MG | 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 |
---|---|---|---|---|---|---|---|
10/30/2007 | ORIG-1 | Approval |
Label is not available on this site. |