ANDA 091135

TRIS PHARMA INC

FDA Drug Application

Application #091135

Documents

• Letter: 2012-05-30
• Review: 2017-05-17

Application Sponsors

ANDA 091135

TRIS PHARMA INC

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;ORAL

EQ 30MG HYDROBROMIDE/5ML

0

DEXTROMETHORPHAN POLISTIREX

DEXTROMETHORPHAN POLISTIREX

FDA Submissions

	ORIG	1	AP	2012-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-10-27

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91135
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROMETHORPHAN POLISTIREX","activeIngredients":"DEXTROMETHORPHAN POLISTIREX","strength":"EQ 30MG HYDROBROMIDE\/5ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROMETHORPHAN POLISTIREX","submission":"DEXTROMETHORPHAN POLISTIREX","actionType":"EQ 30MG HYDROBROMIDE\/5ML","submissionClassification":"SUSPENSION, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)