GLENMARK PHARMS LTD FDA Approval ANDA 206498

ANDA 206498

GLENMARK PHARMS LTD

FDA Drug Application

Application #206498

Application Sponsors

ANDA 206498GLENMARK PHARMS LTD

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL5%0LIDOCAINELIDOCAINE

FDA Submissions

UNKNOWN; ORIG1AP2016-09-09STANDARD
LABELING; LabelingSUPPL2AP2018-11-02STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7

TE Codes

001PrescriptionAT

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206498
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-02
        )

)

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