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
CHOLOGRAFIN MEGLUMINE از شرکت BRACCO
New Drug Application (NDA): 009321
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHOLOGRAFIN MEGLUMINE | IODIPAMIDE MEGLUMINE | 52% | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CHOLOGRAFIN MEGLUMINE | IODIPAMIDE MEGLUMINE | 10.3% | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CHOLOGRAFIN SODIUM | IODIPAMIDE SODIUM | 20% | 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 |
|---|---|---|---|---|---|---|---|
| 04/27/1954 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 04/05/2017 | SUPPL-30 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009321s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009321Orig1s030ltr.pdf |
||
| 07/06/2015 | SUPPL-28 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009321Orig1s028ltr.pdf |
||
| 03/16/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1995 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/29/1994 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1982 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/01/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/16/1977 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1977 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/02/1976 | SUPPL-14 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/05/2017 | SUPPL-30 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009321s030lbl.pdf | |
| 07/06/2015 | SUPPL-28 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf |
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