ANDA 204239

HETERO LABS LTD V

FDA Drug Application

Application #204239

Documents

• Letter: 2015-12-22
• Letter: 2015-04-13

Application Sponsors

ANDA 204239

HETERO LABS LTD V

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

LINEZOLID

LINEZOLID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-21
LABELING; Labeling	SUPPL	2	AP	2019-04-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204239
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204239Orig1s000ltrl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204239Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/02\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-02
        )

)