Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011386
Company: GE HEALTHCARE
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. |
||
| 06/15/1995 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 08/23/1996 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1990 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1990 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/09/1988 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/02/1988 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1986 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/10/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/28/1984 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/12/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/12/1984 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/05/1979 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1977 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/29/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |