ANDA 213501

GLENMARK PHARMS LTD

FDA Drug Application

Application #213501

Application Sponsors

ANDA 213501

GLENMARK PHARMS LTD

Marketing Status

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

Application Products

001	UNKNOWN	UNKNOWN	0	GABAPENTIN ENCARBIL	GABAPENTIN ENCARBIL
002	TABLET, EXTENDED RELEASE;ORAL	600MG	0	GABAPENTIN ENCARBIL	GABAPENTIN ENCARBIL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-12-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213501
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN ENCARBIL","activeIngredients":"GABAPENTIN ENCARBIL","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-29
        )

)