Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017902
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RENOVUE-65 | IODAMIDE MEGLUMINE | 65% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/25/1978 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/11/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/21/1993 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1983 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/26/1983 | SUPPL-4 | Efficacy |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/04/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |