ANDA 213874

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213874

Application Sponsors

ANDA 213874

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

CYANOCOBALAMIN

CYANOCOBALAMIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2022-08-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213874
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYANOCOBALAMIN","activeIngredients":"CYANOCOBALAMIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-08
        )

)