ANDA 205695

ANBISON LAB

FDA Drug Application

Application #205695

Application Sponsors

ANDA 205695

ANBISON LAB

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, CHEWABLE;ORAL	EQ 4MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM
002	TABLET, CHEWABLE;ORAL	EQ 5MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-11-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ANBISON LAB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205695
            [companyName] => ANBISON LAB
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/05\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-05
        )

)