ANDA 205707

MICRO LABS LTD INDIA

FDA Drug Application

Application #205707

Application Sponsors

ANDA 205707

MICRO LABS LTD INDIA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG;EQ 125MG BASE	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM
002	TABLET;ORAL	500MG;EQ 125MG BASE	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-12-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-10-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MICRO LABS LTD INDIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205707
            [companyName] => MICRO LABS LTD INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"250MG;EQ 125MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"500MG;EQ 125MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/23\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-10-23
        )

)