ANDA 215342

AMNEAL EU LTD

FDA Drug Application

Application #215342

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 215342

AMNEAL EU LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INTRAVENOUS

0.5MG/5ML (0.1MG/ML)

0

ATROPINE SULFATE

ATROPINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL EU LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215342
            [companyName] => AMNEAL EU LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-26
        )

)