ANDA 211938

GLAND PHARMA LTD

FDA Drug Application

Application #211938

Application Sponsors

ANDA 211938

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2GM/VIAL

0

CYTARABINE

CYTARABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-10	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

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
        )

)