Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089347
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RENOCAL-76 | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | 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 |
|---|---|---|---|---|---|---|---|
| 06/01/1988 | 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 |
|---|---|---|---|---|---|
| 02/22/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/17/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/01/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |