Application Sponsors
Marketing Status
Discontinued | 002 |
Discontinued | 003 |
Application Products
002 | OINTMENT;TOPICAL | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | ARISTOCORT | TRIAMCINOLONE ACETONIDE |
003 | OINTMENT;TOPICAL | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| ORIG | 1 | AP | 1972-04-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1983-12-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1989-10-13 | |
LABELING; Labeling | SUPPL | 25 | AP | 1989-10-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1989-10-13 | |
Submissions Property Types
SUPPL | 22 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 26 | Null | 0 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 80745
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)