ANDA 206765

ALKEM LABS LTD

FDA Drug Application

Application #206765

Application Sponsors

ANDA 206765

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG

0

DALFAMPRIDINE

DALFAMPRIDINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-30	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-09-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206765
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DALFAMPRIDINE","activeIngredients":"DALFAMPRIDINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-30
        )

)