Drugs@FDA: FDA-Approved Drugs
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SINOGRAFIN | DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE | 52.7%;26.8% | SOLUTION;INTRAUTERINE | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/22/1958 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 08/29/2013 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2000 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1994 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/2002 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11324s28ltr.pdf |
| 01/28/1985 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1983 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1983 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1983 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/11/1979 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/1978 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/31/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1978 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1977 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/31/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/05/1976 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1975 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |