GLAND PHARMA LTD FDA Approval ANDA 211938

ANDA 211938

GLAND PHARMA LTD

FDA Drug Application

Application #211938

Application Sponsors

ANDA 211938GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION2GM/VIAL0CYTARABINECYTARABINE

FDA Submissions

UNKNOWN; ORIG1AP2019-12-23STANDARD
LABELING; LabelingSUPPL2AP2020-11-10STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211938
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYTARABINE","activeIngredients":"CYTARABINE","strength":"2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-23
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.