NDA 022499

TRIS PHARMA INC

FDA Drug Application

Application #022499

Documents

• Label: 2009-12-10
• Summary Review: 2010-05-12
• Letter: 2009-12-11
• Letter: 2010-09-29
• Label: 2010-09-29
• Review: 2010-05-12

Application Sponsors

NDA 022499

TRIS PHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;ORAL

EQ 0.09MG BASE/ML

0

CLONIDINE

CLONIDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2009-12-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22499
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE","activeIngredients":"CLONIDINE","strength":"EQ 0.09MG BASE\/ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/23\/2010","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022499s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022499lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLONIDINE","submission":"CLONIDINE","actionType":"EQ 0.09MG BASE\/ML","submissionClassification":"SUSPENSION, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-09-23
        )

)