ANDA 090877

APOTEX INC

FDA Drug Application

Application #090877

Application Sponsors

ANDA 090877

APOTEX INC

Marketing Status

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

Application Products

001	TABLET;ORAL	35MG	0	RISEDRONATE SODIUM	RISEDRONATE SODIUM
002	TABLET;ORAL	75MG	0	RISEDRONATE SODIUM	RISEDRONATE SODIUM
003	TABLET;ORAL	150MG	0	RISEDRONATE SODIUM	RISEDRONATE SODIUM

FDA Submissions

	ORIG	1	AP	2014-06-10
	ORIG	2	AP	2015-11-30

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90877
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISEDRONATE SODIUM","activeIngredients":"RISEDRONATE SODIUM","strength":"35MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISEDRONATE SODIUM","activeIngredients":"RISEDRONATE SODIUM","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISEDRONATE SODIUM","activeIngredients":"RISEDRONATE SODIUM","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISEDRONATE SODIUM","submission":"RISEDRONATE SODIUM","actionType":"35MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISEDRONATE SODIUM","submission":"RISEDRONATE SODIUM","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISEDRONATE SODIUM","submission":"RISEDRONATE SODIUM","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)