ANDA 091632

TRIS PHARMA INC

FDA Drug Application

Application #091632

Documents

• Review: 2013-02-01

Application Sponsors

ANDA 091632

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;ORAL

EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML

0

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2010-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2017-12-27
LABELING; Labeling	SUPPL	17	AP	2017-12-27	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	7
SUPPL	17	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91632
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX","activeIngredients":"CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX","strength":"EQ 8MG MALEATE\/5ML;EQ 10MG BITARTRATE\/5ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX","submission":"CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX","actionType":"EQ 8MG MALEATE\/5ML;EQ 10MG BITARTRATE\/5ML","submissionClassification":"SUSPENSION, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)