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
CARDIOGEN-82 از شرکت BRACCO
New Drug Application (NDA): 019414
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDIOGEN-82 | RUBIDIUM CHLORIDE RB-82 | N/A | INJECTABLE;INJECTION | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 12/29/1989 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 10/24/2019 | SUPPL-24 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019414Orig1s024ltr.pdf |
||
| 04/26/2019 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019414Orig1s022ltr.pdf |
||
| 10/15/2020 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019414Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019414Orig1s021ltr.pdf |
||
| 12/05/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2012 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019414s014ltr.pdf |
||
| 07/29/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019414s012ltr.pdf |
||
| 07/21/2009 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019414s011ltr.pdf |
||
| 04/05/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19414S6ltr.pdf |
|
| 03/23/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1990 | 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 |
|---|---|---|---|---|---|
| 10/15/2020 | SUPPL-21 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019414Orig1s021lbl.pdf | |
| 10/24/2019 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s024lbl.pdf | |
| 04/26/2019 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s022lbl.pdf | |
| 02/08/2012 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf | |
| 07/29/2010 | SUPPL-12 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf | |
| 07/21/2009 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf |
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