ANDA 091072

APOTEX INC

FDA Drug Application

Application #091072

Application Sponsors

ANDA 091072

APOTEX INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	EQ 1.5MG BASE	0	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE
002	CAPSULE;ORAL	EQ 3MG BASE	0	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE
003	CAPSULE;ORAL	EQ 4.5MG BASE	0	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE
004	CAPSULE;ORAL	EQ 6MG BASE	0	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE

FDA Submissions

	ORIG	1	AP	2013-05-16
LABELING; Labeling	SUPPL	2	AP	2015-07-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-07-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-07-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-07-17	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91072
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 1.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 3MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 4.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 6MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIVASTIGMINE TARTRATE","submission":"RIVASTIGMINE TARTRATE","actionType":"EQ 1.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIVASTIGMINE TARTRATE","submission":"RIVASTIGMINE TARTRATE","actionType":"EQ 3MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIVASTIGMINE TARTRATE","submission":"RIVASTIGMINE TARTRATE","actionType":"EQ 4.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIVASTIGMINE TARTRATE","submission":"RIVASTIGMINE TARTRATE","actionType":"EQ 6MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)