ANDA 075782

VISTAPHARM

FDA Drug Application

Application #075782

Documents

• Letter: 2000-12-22

Application Sponsors

ANDA 075782

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

250MG/5ML

0

VALPROIC ACID

VALPROIC ACID

FDA Submissions

ORIG

1

AP

2000-12-22

TE Codes

001

Prescription

AA

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75782
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROIC ACID","activeIngredients":"VALPROIC ACID","strength":"250MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROIC ACID","submission":"VALPROIC ACID","actionType":"250MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)