ANDA 213279

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213279

Application Sponsors

ANDA 213279

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-01-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-11-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213279
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-14
        )

)