MICRO LABS LTD INDIA FDA Approval ANDA 205187

ANDA 205187

MICRO LABS LTD INDIA

FDA Drug Application

Application #205187

Application Sponsors

ANDA 205187MICRO LABS LTD INDIA

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SUSPENSION;ORAL200MG/5ML;EQ 28.5MG BASE/5ML0AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM
002FOR SUSPENSION;ORAL400MG/5ML;EQ 57MG BASE/5ML0AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-05-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS LTD INDIA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205187
            [companyName] => MICRO LABS LTD INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"200MG\/5ML;EQ 28.5MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"400MG\/5ML;EQ 57MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.