Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ADENOSCAN | ADENOSINE |
| 002 | SOLUTION;INTRAVENOUS | 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ADENOSCAN | ADENOSINE |
FDA Submissions
| TYPE 6; Type 6 - New Indication (no longer used) | ORIG | 1 | AP | 1995-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-10-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1997-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-10-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2001-08-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2005-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2009-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2013-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2014-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2014-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2014-08-20 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 6 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 20059
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"ADENOSCAN","activeIngredients":"ADENOSINE","strength":"60MG\/20ML (3MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADENOSCAN","activeIngredients":"ADENOSINE","strength":"90MG\/30ML (3MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/20\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020059s017s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2014","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020059s017s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020059s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020059s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2001","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20059s7lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ADENOSCAN","submission":"ADENOSINE","actionType":"60MG\/20ML (3MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ADENOSCAN","submission":"ADENOSINE","actionType":"90MG\/30ML (3MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-08-20
)
)