Documents
Application Sponsors
| ANDA 078104 | PERRIGO ISRAEL | |
Marketing Status
| Discontinued | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | SPRAY, METERED;NASAL | 0.055MG/SPRAY | 0 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE |
| 002 | SPRAY, METERED;NASAL | 0.055MG/SPRAY | 0 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| ORIG | 1 | AP | 2009-07-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-11-14 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-11-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2018-05-25 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2020-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2020-11-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 17 | Null | 7 |
CDER Filings
PERRIGO ISRAEL
cder:Array
(
[0] => Array
(
[ApplNo] => 78104
[companyName] => PERRIGO ISRAEL
[docInserts] => ["",""]
[products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.055MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.055MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/30\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/078104lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.055MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.055MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2009-07-30
)
)