ANDA 211521

TARO

FDA Drug Application

Application #211521

Application Sponsors

ANDA 211521

TARO

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 200MG BASE/5ML

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211521
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 200MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-11
        )

)