Drugs@FDA: FDA-Approved Drugs
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINITEC | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 0.22-2.22 CI/GENERATOR | SOLUTION;INJECTION, 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1974 | 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 |
|---|---|---|---|---|---|
| 09/30/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1985 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 05/05/1981 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1980 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 10/22/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/18/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 10/11/1979 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1983 | SUPPL-18 | Efficacy |
Label is not available on this site. |
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| 04/05/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 05/18/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 03/20/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/11/1977 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/15/1977 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1976 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/05/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 12/22/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/02/1975 | SUPPL-7 | Labeling |
Label is not available on this site. |