Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086505
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYPAQUE-76 | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | 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 |
|---|---|---|---|---|---|---|---|
| 07/02/1980 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/29/2001 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 11/19/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 06/16/1995 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 10/11/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/23/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/24/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 01/29/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |