NDA 022500

TRIS PHARMA INC

FDA Drug Application

Application #022500

Documents

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

Application Sponsors

NDA 022500

TRIS PHARMA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 0.17MG BASE	0	CLONIDINE	CLONIDINE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 0.26MG BASE	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

31

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22500
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE","activeIngredients":"CLONIDINE","strength":"EQ 0.17MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONIDINE","activeIngredients":"CLONIDINE","strength":"EQ 0.26MG BASE","dosageForm":"TABLET, 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\\\/022500s001lbl.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\\\/022500lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLONIDINE","submission":"CLONIDINE","actionType":"EQ 0.17MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE","submission":"CLONIDINE","actionType":"EQ 0.26MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-09-23
        )

)