ANDA 040891

NOSTRUM LABS INC

FDA Drug Application

Application #040891

Application Sponsors

ANDA 040891

NOSTRUM LABS INC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

6.25MG/5ML

0

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2009-03-13

TE Codes

001

Prescription

AA

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40891
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)