SUN PHARM INDS LTD FDA Approval ANDA 091280

ANDA 091280

SUN PHARM INDS LTD

FDA Drug Application

Application #091280

Application Sponsors

ANDA 091280SUN PHARM INDS LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.004MG/ML0DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE

FDA Submissions

ORIG1AP2013-01-25

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91280
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESMOPRESSIN ACETATE","activeIngredients":"DESMOPRESSIN ACETATE","strength":"0.004MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESMOPRESSIN ACETATE","submission":"DESMOPRESSIN ACETATE","actionType":"0.004MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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