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
CERETEC از شرکت GE HEALTHCARE
New Drug Application (NDA): 019829
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CERETEC | TECHNETIUM TC-99M EXAMETAZIME KIT | N/A | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/30/1988 | 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 |
|---|---|---|---|---|---|
| 09/19/2018 | SUPPL-34 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019829Orig1s034ltr.pdf |
||
| 04/08/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/2013 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019829Orig1s026ltr.pdf |
||
| 03/08/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019829s019ltr.pdf |
|
| 11/25/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1996 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/25/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1995 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/07/1995 | SUPPL-5 | Efficacy-New Indication |
Label is not available on this site. |
||
| 04/07/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/19/2018 | SUPPL-34 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf | |
| 09/19/2018 | SUPPL-34 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf | |
| 08/05/2013 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf |
نظرات کاربران