ANDA 207235

APOTEX

FDA Drug Application

Application #207235

Documents

• Letter: 2016-08-12

Application Sponsors

ANDA 207235

APOTEX

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

10MG

0

CETIRIZINE HYDROCHLORIDE ALLERGY

CETIRIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-08-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207235
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207235Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-12
        )

)