ANDA 216845

AUROBINDO PHARMA LTD

FDA Drug Application

Application #216845

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 216845

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 500MG BASE	0	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM
002	CAPSULE;ORAL	EQ 500MG BASE	0	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216845
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOXACILLIN SODIUM","activeIngredients":"DICLOXACILLIN SODIUM","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DICLOXACILLIN SODIUM","activeIngredients":"DICLOXACILLIN SODIUM","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-23
        )

)