Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017506
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOPAQUE 280 | CALCIUM; MEGLUMINE; METRIZOIC ACID | 0.35MG/ML;140.1MG/ML;461.8MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1974 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 02/01/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/04/1976 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/10/1974 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |