Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017047
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SETHOTOPE | SELENOMETHIONINE SE-75 | 85-550uCi/ML | 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 |
|---|---|---|---|---|---|---|---|
| 05/07/1973 | 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 |
|---|---|---|---|---|---|
| 04/20/1983 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1983 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/25/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/21/1982 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 05/23/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/21/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/19/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/21/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/08/1976 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/24/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/11/1976 | SUPPL-2 | Labeling |
Label is not available on this site. |