Application Sponsors
Marketing Status
Application Products
001 | CREAM;TOPICAL | 0.025% | 0 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| ORIG | 1 | AP | 1984-10-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1989-12-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-10-06 | |
LABELING; Labeling | SUPPL | 4 | AP | 1989-12-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-05-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-05-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-05-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-05-06 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 88818
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.025%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)