ANDA 209011

CSPC OUYI

FDA Drug Application

Application #209011

Documents

• Letter: 2017-04-21

Application Sponsors

ANDA 209011

CSPC OUYI

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

2017-04-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ADAPTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209011
            [companyName] => ADAPTIS
            [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":"04\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209011Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-18
        )

)