NDA 022220

ALLERGAN

FDA Drug Application

Application #022220

Documents

• Label: 2008-06-19
• Review: 2009-04-01
• Letter: 2008-06-20
• Summary Review: 2008-07-17

Application Sponsors

NDA 022220

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL

8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

TRIVARIS

TRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2008-06-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22220
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIVARIS","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"8MG\/0.1ML (8MG\/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/16\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022220lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRIVARIS","submission":"TRIAMCINOLONE ACETONIDE","actionType":"8MG\/0.1ML (8MG\/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-06-16
        )

)