ANDA 215035

AMNEAL PHARMS LLC

FDA Drug Application

Application #215035

Documents

• Letter: 2023-01-10

Application Sponsors

ANDA 215035

AMNEAL PHARMS LLC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SUSPENSION;ORAL

1MG/ML(150ML)

0

AMLODIPINE BENZOATE

AMLODIPINE BENZOATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-12-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AMNEAL PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215035
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BENZOATE","activeIngredients":"AMLODIPINE BENZOATE","strength":"1MG\/ML(150ML)","dosageForm":"SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-02
        )

)