ANDA 213375

ALKEM LABS LTD

FDA Drug Application

Application #213375

Application Sponsors

ANDA 213375

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

500MG/PACKET

0

VIGABATRIN

VIGABATRIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-12-02	STANDARD
REMS; REMS	SUPPL	3	AP	2022-10-12

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AA

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213375
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-02
        )

)