Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010929
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IODOTOPE | SODIUM IODIDE I-131 | 1-130mCi | CAPSULE;ORAL | Discontinued | None | No | No |
| IODOTOPE | SODIUM IODIDE I-131 | 7-106mCi/BOT | SOLUTION;ORAL | Discontinued | None | No | No |
| IODOTOPE | SODIUM IODIDE I-131 | 1-150mCi | 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 |
|---|---|---|---|---|---|---|---|
| 05/02/1957 | 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 |
|---|---|---|---|---|---|
| 08/14/2001 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1998 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/05/1995 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/09/1995 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/30/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1986 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 08/08/1980 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/07/1980 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 11/06/1979 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 05/01/1979 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/30/1978 | SUPPL-24 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 01/22/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 02/23/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 12/14/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/07/1977 | SUPPL-16 | Labeling |
Label is not available on this site. |