Drugs@FDA: FDA-Approved Drugs
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYPAQUE | DIATRIZOATE SODIUM | 50% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HYPAQUE | DIATRIZOATE SODIUM | 25% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HYPAQUE SODIUM 20% | DIATRIZOATE SODIUM | 20% | SOLUTION;URETERAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/26/1954 | 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 |
|---|---|---|---|---|---|
| 08/13/2001 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/20/1998 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/15/1995 | SUPPL-77 | Labeling |
Label is not available on this site. |
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| 08/23/1996 | SUPPL-76 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/05/1993 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1991 | SUPPL-73 | Labeling |
Label is not available on this site. |
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| 10/03/1991 | SUPPL-72 | Labeling |
Label is not available on this site. |
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| 10/03/1991 | SUPPL-71 | Labeling |
Label is not available on this site. |
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| 06/29/1989 | SUPPL-70 | Labeling |
Label is not available on this site. |
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| 05/26/1989 | SUPPL-69 | Labeling |
Label is not available on this site. |
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| 05/02/1989 | SUPPL-68 | Labeling |
Label is not available on this site. |
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| 04/11/1989 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1988 | SUPPL-66 | Labeling |
Label is not available on this site. |
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| 08/24/1987 | SUPPL-64 | Labeling |
Label is not available on this site. |
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| 11/07/1986 | SUPPL-63 | Labeling |
Label is not available on this site. |
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| 02/26/1990 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/25/1986 | SUPPL-61 | Labeling |
Label is not available on this site. |
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| 03/17/1986 | SUPPL-60 | Labeling |
Label is not available on this site. |
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| 08/14/1986 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1985 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 04/19/1985 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 05/23/1988 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/23/1987 | SUPPL-55 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/14/1985 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/18/1982 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1983 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/18/1982 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/01/1987 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 02/24/1982 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 04/05/1984 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 02/29/1984 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 01/18/1982 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/06/1986 | SUPPL-42 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 04/11/1981 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1982 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 10/11/1979 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/22/1979 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/15/1979 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/01/1978 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/31/1978 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1977 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/06/1978 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 02/23/1977 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 09/08/1976 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1976 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/02/1976 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1976 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 06/02/1976 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 02/11/1976 | SUPPL-22 | Labeling |
Label is not available on this site. |