ANDA 076477

SUN PHARM INDS LTD

FDA Drug Application

Application #076477

Documents

• Letter: 2011-12-01
• Review: 2014-07-07

Application Sponsors

ANDA 076477

SUN PHARM INDS 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

	ORIG	1	AP	2011-11-30
LABELING; Labeling	SUPPL	3	AP	2012-04-20
LABELING; Labeling	SUPPL	5	AP	2013-01-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-09-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-06-08	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-06-08	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-06-08	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-06-08	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-06-08	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-06-08	STANDARD
LABELING; Labeling	SUPPL	27	AP	2021-06-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	10	Null	7
SUPPL	12	Null	15
SUPPL	15	Null	15
SUPPL	17	Null	7
SUPPL	23	Null	7
SUPPL	26	Null	15
SUPPL	27	Null	15

TE Codes

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

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76477
            [companyName] => SUN PHARM INDS 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":"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
        )

)