ANDA 213561

HIKMA

FDA Drug Application

Application #213561

Application Sponsors

ANDA 213561

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL

8MG/20ML (0.4MG/ML)

0

ATROPINE SULFATE

ATROPINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213561
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"8MG\/20ML (0.4MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-01
        )

)