Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012968
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORAGRAFIN CALCIUM | IPODATE CALCIUM | 3GM/PACKET | GRANULE;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 |
|---|---|---|---|---|---|---|---|
| 03/15/1962 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 05/06/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/08/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/09/1976 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/24/1975 | SUPPL-6 | Labeling |
Label is not available on this site. |