ANDA 205187

MICRO LABS LTD INDIA

FDA Drug Application

Application #205187

Application Sponsors

ANDA 205187

MICRO LABS LTD INDIA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	200MG/5ML;EQ 28.5MG BASE/5ML	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM
002	FOR SUSPENSION;ORAL	400MG/5ML;EQ 57MG BASE/5ML	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)