Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016923
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESULOID | TECHNETIUM TC-99M SULFUR COLLOID KIT | N/A | 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 |
|---|---|---|---|---|---|---|---|
| 06/10/1974 | 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 |
|---|---|---|---|---|---|
| 01/25/1991 | SUPPL-20 | Efficacy-New Indication |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/18/1988 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/23/1985 | SUPPL-17 | Efficacy |
Label is not available on this site. |
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| 09/30/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1983 | 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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| 07/20/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/10/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 08/02/1983 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/25/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/30/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/20/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/31/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/31/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/15/1976 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1976 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/22/1975 | SUPPL-1 | Labeling |
Label is not available on this site. |