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
ADENOSCAN از شرکت ASTELLAS
New Drug Application (NDA): 020059
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADENOSCAN | ADENOSINE | 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION;INTRAVENOUS | Discontinued |
None |
Yes | No |
| ADENOSCAN | ADENOSINE | 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION;INTRAVENOUS | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/18/1995 | ORIG-1 | Approval |
Type 6 – New Indication (no longer used) |
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 |
|---|---|---|---|---|---|
| 08/20/2014 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf |
||
| 08/20/2014 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf |
||
| 01/03/2014 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s016ltr.pdf |
||
| 12/09/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2009 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020059s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020059s014ltr.pdf |
||
| 07/14/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf |
|
| 02/01/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20059s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20059s7ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-059S007_Adenoscan.pdf |
||
| 10/26/1999 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/07/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/20/2014 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf | |
| 08/20/2014 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf | |
| 01/03/2014 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf | |
| 11/06/2009 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020059s014lbl.pdf | |
| 08/31/2001 | SUPPL-7 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20059s7lbl.pdf |
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