Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077780
Company: TARO
Company: TARO
| 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 |
|---|---|---|---|---|---|---|---|
| 09/05/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077780s000_ltr.pdf |