Documents
Application Sponsors
Marketing Status
Application Products
002 | INJECTABLE;INJECTION | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ADENOCARD | ADENOSINE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1989-10-30 | PRIORITY |
LABELING; Labeling | SUPPL | 2 | AP | 1990-05-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-04-25 | PRIORITY |
LABELING; Labeling | SUPPL | 4 | AP | 1990-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1990-11-15 | PRIORITY |
LABELING; Labeling | SUPPL | 7 | AP | 1992-06-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1993-10-27 | PRIORITY |
LABELING; Labeling | SUPPL | 9 | AP | 1995-06-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-06-26 | PRIORITY |
LABELING; Labeling | SUPPL | 11 | AP | 1996-02-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-12-27 | PRIORITY |
LABELING; Labeling | SUPPL | 13 | AP | 1996-07-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-02-13 | PRIORITY |
LABELING; Labeling | SUPPL | 15 | AP | 1999-04-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-11-02 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-02-01 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-09-21 | PRIORITY |
LABELING; Labeling | SUPPL | 21 | AP | 2005-07-14 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2009-11-06 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2011-02-23 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2013-12-13 | PRIORITY |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 24 | Null | 7 |
SUPPL | 26 | Null | 7 |
SUPPL | 28 | Null | 0 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 19937
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"ADENOCARD","activeIngredients":"ADENOSINE","strength":"3MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/06\/2009","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019937s024lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ADENOCARD","submission":"ADENOSINE","actionType":"3MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2009-11-06
)
)