ANDA 090638

AKORN

FDA Drug Application

Application #090638

Documents

• Letter: 2012-08-24

Application Sponsors

ANDA 090638

AKORN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

2%

0

NEDOCROMIL SODIUM

NEDOCROMIL SODIUM

FDA Submissions

ORIG

1

AP

2012-08-22

Submissions Property Types

ORIG

1

Null

3

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90638
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEDOCROMIL SODIUM","activeIngredients":"NEDOCROMIL SODIUM","strength":"2%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEDOCROMIL SODIUM","submission":"NEDOCROMIL SODIUM","actionType":"2%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)