ANDA 205006

GLENMARK PHARMS LTD

FDA Drug Application

Application #205006

Documents

• Letter: 2015-10-30

Application Sponsors

ANDA 205006

GLENMARK PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET;ORAL	50MG	0	LACOSAMIDE	LACOSAMIDE
002	TABLET;ORAL	100MG	0	LACOSAMIDE	LACOSAMIDE
003	TABLET;ORAL	150MG	0	LACOSAMIDE	LACOSAMIDE
004	TABLET;ORAL	200MG	0	LACOSAMIDE	LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-10-28

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205006
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205006Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-10-28
        )

)