Drugs@FDA: FDA-Approved Drugs
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TECHNETIUM TC 99M TSC | 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 |
---|---|---|---|---|---|---|---|
11/18/1976 | 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 |
---|---|---|---|---|---|
12/15/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
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02/17/1989 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/23/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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07/02/1987 | SUPPL-15 | Efficacy-New Patient Population |
Label is not available on this site. |
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04/19/1985 | SUPPL-14 | Labeling |
Label is not available on this site. |
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12/07/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
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12/07/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/27/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
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08/12/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
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08/28/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/09/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/12/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/13/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/09/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/09/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |