ANDA 211968

NEPHRON

FDA Drug Application

Application #211968

Application Sponsors

ANDA 211968

NEPHRON

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

9MG/ML

0

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211968
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"9MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-23
        )

)