ANDA 214970

MEDEFIL INC

FDA Drug Application

Application #214970

Application Sponsors

ANDA 214970

MEDEFIL INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

1MG/10ML (0.1MG/ML)

0

ATROPINE SULFATE

ATROPINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-04

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MEDEFIL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214970
            [companyName] => MEDEFIL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATROPINE SULFATE","submission":"ATROPINE SULFATE","actionType":"1MG\/10ML (0.1MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)