ANDA 210118

TEVA PHARMS USA

FDA Drug Application

Application #210118

Documents

• Letter: 2019-08-06

Application Sponsors

ANDA 210118

TEVA PHARMS USA

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	2019-07-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-09-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210118
            [companyName] => TEVA PHARMS USA
            [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":"07\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210118Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-25
        )

)