ANDA 216146

GLAND PHARMA LTD

FDA Drug Application

Application #216146

Application Sponsors

ANDA 216146

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

50MG/ML (50MG/ML)

0

EPHEDRINE SULFATE

EPHEDRINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216146
            [companyName] => GLAND PHARMA LTD
            [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":"EPHEDRINE SULFATE","submission":"EPHEDRINE SULFATE","actionType":"50MG\/ML (50MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)