ANDA 205517

ALKEM LABS LTD

FDA Drug Application

Application #205517

Documents

• Letter: 2015-09-01

Application Sponsors

ANDA 205517

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

LINEZOLID

LINEZOLID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-02-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205517
            [companyName] => ALKEM LABS LTD
            [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":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205517Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/31\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-12-31
        )

)