Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077316
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| 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/2007/077316s000_ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/23/2025 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/03/2020 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/04/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2013 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/21/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/14/2011 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |