ANDA 205180

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #205180

Application Sponsors

ANDA 205180

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

25MG/5ML

0

NITROFURANTOIN

NITROFURANTOIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-05-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205180
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN","strength":"25MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-05-03
        )

)