Application Sponsors
ANDA 084343 | DELCOR ASSET CORP | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | LOTION;TOPICAL | 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | KENALOG | TRIAMCINOLONE ACETONIDE |
002 | LOTION;TOPICAL | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | KENALOG | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| ORIG | 1 | AP | 1974-07-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1981-12-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1981-12-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1981-12-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1982-06-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1982-12-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1983-05-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1983-06-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1992-11-09 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 31 | Null | 0 |
CDER Filings
DELCOR ASSET CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 84343
[companyName] => DELCOR ASSET CORP
[docInserts] => ["",""]
[products] => [{"drugName":"KENALOG","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KENALOG","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"KENALOG","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KENALOG","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)