Application Sponsors
Marketing Status
Application Products
004 | SYRUP;ORAL | 2MG/5ML | 0 | ARISTOCORT | TRIAMCINOLONE DIACETATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1959-09-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1979-02-26 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 1993-11-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1992-02-06 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 11960
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE DIACETATE","strength":"2MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE DIACETATE","actionType":"2MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)