NDA 021023

ALLERGAN

FDA Drug Application

Application #021023

Documents

• Review: 2005-04-08

Application Sponsors

NDA 021023

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

EMULSION; OPHTHALMIC

0.05%

0

RESTASIS

CYCLOSPORINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2003-10-10

PRIORITY

Submissions Property Types

ORIG

1

Null

0

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21023
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"RESTASIS","activeIngredients":"CYCLOSPORINE","strength":"0.05%","dosageForm":"EMULSION; OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RESTASIS","submission":"CYCLOSPORINE","actionType":"0.05%","submissionClassification":"EMULSION; OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)