ANDA 214805

MILLA PHARMS

FDA Drug Application

Application #214805

Documents

• Letter: 2021-06-15

Application Sponsors

ANDA 214805

MILLA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MEQ/ML

0

SODIUM ACETATE

SODIUM ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-04

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MILLA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214805
            [companyName] => MILLA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM ACETATE","activeIngredients":"SODIUM ACETATE","strength":"2MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-04
        )

)