ANDA 209825

GLAND PHARMA LTD

FDA Drug Application

Application #209825

Application Sponsors

ANDA 209825

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

DOXORUBICIN HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-07-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-07-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209825
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-11
        )

)