ANDA 210702

CELLTRION

FDA Drug Application

Application #210702

Application Sponsors

ANDA 210702

CELLTRION

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

LINEZOLID

LINEZOLID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-02-19	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210702
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/19\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/01\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-02-19
        )

)