ANDA 040649

SLATE

FDA Drug Application

Application #040649

Application Sponsors

ANDA 040649

SLATE

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

15MG/5ML;6.25MG/5ML

0

PROMETHAZINE DM

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2006-02-14

TE Codes

001

Prescription

AA

CDER Filings

SLATE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40649
            [companyName] => SLATE
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE DM","activeIngredients":"DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE","strength":"15MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE DM","submission":"DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE","actionType":"15MG\/5ML;6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)