اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
AMIPAQUE از شرکت GE HEALTHCARE
New Drug Application (NDA): 017982
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIPAQUE | METRIZAMIDE | 3.75GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMIPAQUE | METRIZAMIDE | 6.75GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMIPAQUE | METRIZAMIDE | 2.5GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMIPAQUE | METRIZAMIDE | 13.5GM/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/23/1978 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 05/31/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/20/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/04/1987 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/23/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1983 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/12/1983 | SUPPL-17 | Efficacy |
Label is not available on this site. |
||
| 07/09/1982 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/02/1981 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1981 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1983 | SUPPL-6 | Efficacy |
Label is not available on this site. |
||
| 02/29/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/29/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
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