ANDA 213222

GLENMARK PHARMS LTD

FDA Drug Application

Application #213222

Application Sponsors

ANDA 213222

GLENMARK PHARMS LTD

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

2021-05-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213222
            [companyName] => GLENMARK PHARMS LTD
            [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":"ICATIBANT ACETATE","submission":"ICATIBANT ACETATE","actionType":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)