ANDA 203533

MACLEODS PHARMS LTD

FDA Drug Application

Application #203533

Application Sponsors

ANDA 203533

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	5MG	0	RISEDRONATE SODIUM	RISEDRONATE SODIUM
002	TABLET;ORAL	30MG	0	RISEDRONATE SODIUM	RISEDRONATE SODIUM
003	TABLET;ORAL	35MG	0	RISEDRONATE SODIUM	RISEDRONATE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-09
UNKNOWN;	ORIG	2	AP	2016-11-29

Submissions Property Types

ORIG	1	Null	17
ORIG	2	Null	19

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203533
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISEDRONATE SODIUM","activeIngredients":"RISEDRONATE SODIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISEDRONATE SODIUM","activeIngredients":"RISEDRONATE SODIUM","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISEDRONATE SODIUM","activeIngredients":"RISEDRONATE SODIUM","strength":"35MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2016","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/09\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-29
        )

)