ANDA 211813

HETERO LABS

FDA Drug Application

Application #211813

Application Sponsors

ANDA 211813

HETERO LABS

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

100MG/5ML

0

LINEZOLID

LINEZOLID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211813
            [companyName] => HETERO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"100MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-31
        )

)