GLENMARK PHARMS LTD FDA Approval ANDA 213501

ANDA 213501

GLENMARK PHARMS LTD

FDA Drug Application

Application #213501

Application Sponsors

ANDA 213501GLENMARK PHARMS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001UNKNOWNUNKNOWN0GABAPENTIN ENCARBILGABAPENTIN ENCARBIL

FDA Submissions

UNKNOWN; ORIG1TA2020-12-29STANDARD

Submissions Property Types

ORIG1Null31

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
        )

)

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