Application Sponsors
ANDA 087799 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
001 | OINTMENT;TOPICAL | 0.1% | 0 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| ORIG | 1 | AP | 1982-06-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1983-03-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-12-20 | |
LABELING; Labeling | SUPPL | 5 | AP | 1991-02-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1989-07-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1989-07-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-02-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-02-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-02-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-09-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-09-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-09-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-06-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-09-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-12-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-05-30 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 87799
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)