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 | 100% | FOR SOLUTION;ORAL, RECTAL | Discontinued | None | No | No |
HYPAQUE | DIATRIZOATE SODIUM | 40% | SOLUTION;ORAL, RECTAL | 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 |
---|---|---|---|---|---|---|---|
03/26/1956 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
09/30/1994 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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06/15/1995 | SUPPL-33 | Labeling |
Label is not available on this site. |
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08/23/1996 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/05/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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08/01/1990 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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08/01/1990 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/09/1988 | SUPPL-27 | Labeling |
Label is not available on this site. |
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08/02/1988 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/14/1986 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
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02/10/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
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12/28/1984 | SUPPL-22 | Labeling |
Label is not available on this site. |
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09/12/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
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05/29/1991 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/30/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
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01/12/1984 | SUPPL-15 | Labeling |
Label is not available on this site. |
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07/05/1979 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/13/1977 | SUPPL-13 | Labeling |
Label is not available on this site. |
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09/29/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |