Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020059
Company: ASTELLAS
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ADENOSCAN | ADENOSINE | 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
ADENOSCAN | ADENOSINE | 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Letter (PDF)
|
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 |
Label (PDF)
Letter (PDF) Review (PDF) |
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 |