ANDA 065394

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #065394

Application Sponsors

ANDA 065394

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

125MG/5ML

0

GRISEOFULVIN

GRISEOFULVIN, MICROSIZE

FDA Submissions

ORIG

1

AP

2007-07-06

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65394
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRISEOFULVIN","activeIngredients":"GRISEOFULVIN, MICROSIZE","strength":"125MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GRISEOFULVIN","submission":"GRISEOFULVIN, MICROSIZE","actionType":"125MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)