ANDA 212266

QUAGEN

FDA Drug Application

Application #212266

Documents

• Label: 2020-05-20
• Medication Guide: 2020-05-20

Application Sponsors

ANDA 212266

QUAGEN

Marketing Status

• Over-the-counter: 001

Application Products

001

SYRUP;ORAL

5MG/5ML

0

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

CETIRIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

QUAGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212266
            [companyName] => QUAGEN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/212266s000lbl.pdf#page=14"]
            [products] => [{"drugName":"CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/16\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212266s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212266s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-05-16
        )

)