GLAND PHARMA LTD FDA Approval ANDA 076774

ANDA 076774

GLAND PHARMA LTD

FDA Drug Application

Application #076774

Application Sponsors

ANDA 076774GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 5MG BASE/ML0HALOPERIDOLHALOPERIDOL LACTATE

FDA Submissions

ORIG1AP2004-08-25
LABELING; LabelingSUPPL4AP2018-06-08STANDARD
LABELING; LabelingSUPPL5AP2018-06-08STANDARD
LABELING; LabelingSUPPL7AP2018-06-08STANDARD

Submissions Property Types

SUPPL4Null15
SUPPL5Null15
SUPPL7Null15

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76774
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL LACTATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL LACTATE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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