ANDA 215825

AGGREGA PHARMA, LLC

FDA Drug Application

Application #215825

Application Sponsors

ANDA 215825

AGGREGA PHARMA, LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

50MG/ML (50MG/ML)

0

EPHEDRINE SULFATE

EPHEDRINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

AGGREGA PHARMA, LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215825
            [companyName] => AGGREGA PHARMA, LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPHEDRINE SULFATE","activeIngredients":"EPHEDRINE SULFATE","strength":"50MG\/ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-21
        )

)