Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074288
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/24/1995 | 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 |
|---|---|---|---|---|---|
| 03/28/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/26/2014 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/04/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/23/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |