ANDA 090548

APOTEX INC

FDA Drug Application

Application #090548

Documents

• Review: 2015-03-09

Application Sponsors

ANDA 090548

APOTEX INC

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 10MG BASE	0	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM
002	TABLET;ORAL	EQ 20MG BASE	0	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM
003	TABLET;ORAL	EQ 40MG BASE	0	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM
004	TABLET;ORAL	EQ 80MG BASE	0	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM

FDA Submissions

	ORIG	1	AP	2012-05-29
LABELING; Labeling	SUPPL	3	AP	2015-04-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-04-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-06-07	STANDARD
LABELING; Labeling	SUPPL	17	AP	2018-06-07	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-01-17	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-11-04	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	19	Null	7
SUPPL	23	Null	7

TE Codes

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

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90548
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 80MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATORVASTATIN CALCIUM","submission":"ATORVASTATIN CALCIUM","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATORVASTATIN CALCIUM","submission":"ATORVASTATIN CALCIUM","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATORVASTATIN CALCIUM","submission":"ATORVASTATIN CALCIUM","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATORVASTATIN CALCIUM","submission":"ATORVASTATIN CALCIUM","actionType":"EQ 80MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)