GLENMARK PHARMS LTD FDA Approval ANDA 213222

ANDA 213222

GLENMARK PHARMS LTD

FDA Drug Application

Application #213222

Application Sponsors

ANDA 213222GLENMARK PHARMS LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;SUBCUTANEOUSEQ 30MG BASE/3ML (EQ 10MG BASE/ML)0ICATIBANT ACETATEICATIBANT ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213222
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICATIBANT ACETATE","activeIngredients":"ICATIBANT ACETATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ICATIBANT ACETATE","submission":"ICATIBANT ACETATE","actionType":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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