ANDA 091687

TRIS PHARMA INC

FDA Drug Application

Application #091687

Application Sponsors

ANDA 091687

TRIS PHARMA INC

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	SYRUP;ORAL	15MG/5ML;6.25MG/5ML	0	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
002	TABLET, CHEWABLE, TABLET, CAPSULE; ORAL	15MG/5ML	0	PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2012-06-28

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91687
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE","activeIngredients":"DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE","strength":"15MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE","strength":"15MG\/5ML","dosageForm":"TABLET, CHEWABLE, TABLET, CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE","submission":"DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE","actionType":"15MG\/5ML;6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE","submission":"PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE","actionType":"15MG\/5ML","submissionClassification":"TABLET, CHEWABLE, TABLET, CAPSULE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)