ANDA 211021

JIANGSU HANSOH PHARM

FDA Drug Application

Application #211021

Application Sponsors

ANDA 211021

JIANGSU HANSOH PHARM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

0

ICATIBANT ACETATE

ICATIBANT ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-03-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-09-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AP

CDER Filings

JIANGSU HANSOH PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211021
            [companyName] => JIANGSU HANSOH PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICATIBANT ACETATE","activeIngredients":"ICATIBANT ACETATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-25
        )

)