ANDA 200386

TRIS PHARMA INC

FDA Drug Application

Application #200386

Application Sponsors

ANDA 200386

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

10MG/5ML;6.25MG/5ML

0

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-06-29
LABELING; Labeling	SUPPL	2	AP	2013-05-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2018-06-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-06-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	8	Null	15

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200386
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE","activeIngredients":"CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE","strength":"10MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/28\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/13\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-06-28
        )

)