ANDA 090372

DR REDDYS LABS LTD

FDA Drug Application

Application #090372

Documents

• Letter: 2010-11-22

Application Sponsors

ANDA 090372

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	10MG	0	ZAFIRLUKAST	ZAFIRLUKAST
002	TABLET;ORAL	20MG	0	ZAFIRLUKAST	ZAFIRLUKAST

FDA Submissions

	ORIG	1	AP	2010-11-18
LABELING; Labeling	SUPPL	2	AP	2014-03-07	STANDARD

Submissions Property Types

ORIG	1	Null	3
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90372
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZAFIRLUKAST","activeIngredients":"ZAFIRLUKAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZAFIRLUKAST","activeIngredients":"ZAFIRLUKAST","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZAFIRLUKAST","submission":"ZAFIRLUKAST","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZAFIRLUKAST","submission":"ZAFIRLUKAST","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)