ANDA 204991

LUPIN LTD

FDA Drug Application

Application #204991

Application Sponsors

ANDA 204991

LUPIN LTD

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

UNKNOWN;	ORIG	1	AP	2019-03-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-10-16	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-05-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-05-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

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

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204991
            [companyName] => LUPIN LTD
            [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":"03\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/16\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-16
        )

)