ANDA 209371

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209371

Documents

• Letter: 2019-05-21

Application Sponsors

ANDA 209371

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	125MG/5ML;EQ 31.25MG BASE/5ML	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM
002	FOR SUSPENSION;ORAL	250MG/5ML;EQ 62.5MG BASE/5ML	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-19

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] => 209371
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"125MG\/5ML;EQ 31.25MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"250MG\/5ML;EQ 62.5MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209371Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-19
        )

)