ANDA 213255

MYLAN

FDA Drug Application

Application #213255

Application Sponsors

ANDA 213255

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

1GM/100ML (10MG/ML)

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213255
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN","submission":"ACETAMINOPHEN","actionType":"1GM\/100ML (10MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)