Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075831
Company: DASH PHARMS NATCO
Company: DASH PHARMS NATCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/14/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/29/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |