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
ADENOCARD از شرکت ASTELLAS
New Drug Application (NDA): 019937
Company: ASTELLAS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADENOCARD | ADENOSINE | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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 |
---|---|---|---|---|---|---|---|
10/30/1989 | 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 |
---|---|---|---|---|---|
12/13/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/23/2011 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
11/06/2009 | SUPPL-24 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019937s024ltr.pdf |
||
07/14/2005 | SUPPL-21 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf |
|
09/21/2001 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/01/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/20/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
02/13/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/29/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
12/27/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/09/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
06/26/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/09/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
10/27/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/11/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
11/15/1990 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/13/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/25/1994 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/10/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/04/1989 | 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 |
---|---|---|---|---|---|
11/06/2009 | SUPPL-24 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf |
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