ANDA 207321

GLAND PHARMA LTD

FDA Drug Application

Application #207321

Application Sponsors

ANDA 207321

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	0	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207321
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXRAZOXANE HYDROCHLORIDE","activeIngredients":"DEXRAZOXANE HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXRAZOXANE HYDROCHLORIDE","activeIngredients":"DEXRAZOXANE HYDROCHLORIDE","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-28
        )

)