ANDA 203384

CHARTWELL RX

FDA Drug Application

Application #203384

Documents

• Letter: 2016-12-09

Application Sponsors

ANDA 203384

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.05%

0

EPINASTINE HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-12-07

Submissions Property Types

ORIG

1

Null

15

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203384
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINASTINE HYDROCHLORIDE","activeIngredients":"EPINASTINE HYDROCHLORIDE","strength":"0.05%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203384Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-07
        )

)