Drugs@FDA: FDA-Approved Drugs
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYPAQUE | DIATRIZOATE MEGLUMINE | 60% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HYPAQUE | DIATRIZOATE MEGLUMINE | 30% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HYPAQUE-CYSTO | DIATRIZOATE MEGLUMINE | 30% | SOLUTION;URETHRAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/21/1969 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 09/30/2002 | SUPPL-71 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16403slr071ltr.pdf |
| 08/13/2001 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1998 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/15/1995 | SUPPL-68 | Labeling |
Label is not available on this site. |
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| 03/25/1994 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1991 | SUPPL-66 | Labeling |
Label is not available on this site. |
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| 10/03/1991 | SUPPL-65 | Labeling |
Label is not available on this site. |
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| 10/03/1991 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 04/24/1991 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1989 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-61 | Labeling |
Label is not available on this site. |
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| 05/26/1989 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 04/18/1989 | SUPPL-58 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/22/1989 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1989 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/11/1989 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1988 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 02/26/1990 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1986 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 11/22/1985 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 04/16/1985 | SUPPL-50 | Labeling |
Label is not available on this site. |
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| 04/23/1985 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 04/19/1985 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 11/26/1984 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 05/23/1988 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/25/1983 | SUPPL-45 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/14/1985 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1984 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 09/11/1985 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/28/1983 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1982 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/12/1984 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 01/24/1984 | SUPPL-37 | Efficacy |
Label is not available on this site. |
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| 02/24/1982 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/16/1984 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/18/1982 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1983 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/11/1981 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1981 | SUPPL-31 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/17/1979 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1978 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1978 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1978 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1978 | SUPPL-23 | Efficacy |
Label is not available on this site. |
||
| 04/01/1977 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 06/02/1976 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1976 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1976 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1976 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/21/1976 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/22/1975 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/29/1975 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/29/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |