Drugs@FDA: FDA-Approved Drugs
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORAGRAFIN SODIUM | IPODATE SODIUM | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1962 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/17/1992 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1988 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 09/25/1986 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/29/1985 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1982 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/10/1982 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/18/1980 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/18/1980 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1979 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 04/17/1979 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/1978 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1978 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/07/1978 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/01/1977 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/07/1978 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1976 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/19/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1975 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/19/1975 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1975 | SUPPL-9 | Labeling |
Label is not available on this site. |