GLAND PHARMA LTD FDA Approval ANDA 216648

ANDA 216648

GLAND PHARMA LTD

FDA Drug Application

Application #216648

Application Sponsors

ANDA 216648GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION40MG/VIAL0MITOMYCINMITOMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2022-11-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216648
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MITOMYCIN","activeIngredients":"MITOMYCIN","strength":"40MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MITOMYCIN","submission":"MITOMYCIN","actionType":"40MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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