ANDA 213171

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213171

Application Sponsors

ANDA 213171

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

500MG/VIAL

0

DAPTOMYCIN

DAPTOMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-09-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-11-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213171
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-02
        )

)