Application Sponsors
Marketing Status
Discontinued | 004 |
Discontinued | 007 |
Discontinued | 009 |
Discontinued | 010 |
Discontinued | 011 |
Application Products
004 | TABLET;ORAL | 2MG | 0 | ARISTOCORT | TRIAMCINOLONE |
007 | TABLET;ORAL | 4MG | 0 | ARISTOCORT | TRIAMCINOLONE |
009 | TABLET;ORAL | 1MG | 0 | ARISTOCORT | TRIAMCINOLONE |
010 | TABLET;ORAL | 16MG | 0 | ARISTOCORT | TRIAMCINOLONE |
011 | TABLET;ORAL | 8MG | 0 | ARISTOCORT | TRIAMCINOLONE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1957-12-03 | PRIORITY |
LABELING; Labeling | SUPPL | 39 | AP | 2009-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1979-08-06 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1981-04-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1982-06-11 | PRIORITY |
LABELING; Labeling | SUPPL | 44 | AP | 2009-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1986-11-29 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1986-09-25 | PRIORITY |
LABELING; Labeling | SUPPL | 47 | AP | 2009-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1994-03-30 | PRIORITY |
LABELING; Labeling | SUPPL | 49 | AP | 1993-09-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1994-10-18 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1999-09-17 | PRIORITY |
Submissions Property Types
SUPPL | 40 | Null | 0 |
SUPPL | 42 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 45 | Null | 0 |
SUPPL | 46 | Null | 0 |
SUPPL | 48 | Null | 0 |
SUPPL | 50 | Null | 0 |
SUPPL | 51 | Null | 0 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 11161
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"16MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)