NDA 209552

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209552

Documents

• Letter: 2018-12-19
• Review: 2018-12-26

Application Sponsors

NDA 209552

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

50MG/50ML (1MG/ML)

0

ARGATROBAN IN SODIUM CHLORIDE

ARGATROBAN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2018-11-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209552
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN IN SODIUM CHLORIDE","activeIngredients":"ARGATROBAN","strength":"50MG\/50ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209552Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209552Orig1s000TOC.cfm\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-27
        )

)