ANDA 203352

JUBILANT CADISTA

FDA Drug Application

Application #203352

Documents

• Letter: 2016-05-24

Application Sponsors

ANDA 203352

JUBILANT CADISTA

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

2016-05-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203352
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"9MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203352Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-05-18
        )

)