ANDA 214331

BAXTER HLTHCARE CORP

FDA Drug Application

Application #214331

Application Sponsors

ANDA 214331

BAXTER HLTHCARE CORP

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INTRAVENOUS

1GM/100ML (10MG/ML)

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-07-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214331
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-19
        )

)