Drugs@FDA: FDA-Approved Drugs
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYPAQUE-M,75% | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 50%;25% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HYPAQUE-M,90% | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 60%;30% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/09/1955 | 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 |
|---|---|---|---|---|---|
| 03/25/1994 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/04/1990 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 10/03/1991 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 04/24/1991 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/1989 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 05/19/1989 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 04/11/1989 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1990 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/25/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 06/25/1986 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 07/24/1985 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 06/26/1985 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 09/13/1984 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 05/23/1988 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/30/1983 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/28/1983 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/1984 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 02/17/1979 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1978 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 02/01/1978 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/01/1978 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 04/08/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/26/1976 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/21/1976 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 01/21/1976 | SUPPL-21 |
Label is not available on this site. |
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| 01/29/1974 | SUPPL-17 | Labeling |
Label is not available on this site. |