Application Sponsors
ANDA 083943 | DELCOR ASSET CORP | |
Marketing Status
Application Products
001 | CREAM;TOPICAL | 0.5% | 0 | KENALOG | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| ORIG | 1 | AP | 1974-01-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1982-06-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1982-04-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1982-04-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1983-05-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1984-03-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1986-06-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1988-02-10 | |
LABELING; Labeling | SUPPL | 34 | AP | 1988-04-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1996-05-14 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 34 | Null | 0 |
SUPPL | 35 | Null | 0 |
CDER Filings
DELCOR ASSET CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 83943
[companyName] => DELCOR ASSET CORP
[docInserts] => ["",""]
[products] => [{"drugName":"KENALOG","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"KENALOG","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)