Application Sponsors
NDA 012515 | DELCOR ASSET CORP | |
Marketing Status
Application Products
001 | SYRUP;ORAL | EQ 4MG BASE/5ML | 0 | KENACORT | TRIAMCINOLONE DIACETATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1961-03-21 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2009-03-13 | |
LABELING; Labeling | SUPPL | 12 | AP | 1978-11-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1979-07-17 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2009-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1979-08-21 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2009-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1982-06-30 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 1993-09-07 | |
Submissions Property Types
SUPPL | 15 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 19 | Null | 0 |
CDER Filings
DELCOR ASSET CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 12515
[companyName] => DELCOR ASSET CORP
[docInserts] => ["",""]
[products] => [{"drugName":"KENACORT","activeIngredients":"TRIAMCINOLONE DIACETATE","strength":"EQ 4MG BASE\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"KENACORT","submission":"TRIAMCINOLONE DIACETATE","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)