ANDA 091226

MYLAN PHARMS INC

FDA Drug Application

Application #091226

Documents

• Review: 2015-03-09
• Review: 2019-01-15

Application Sponsors

ANDA 091226

MYLAN PHARMS 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	2	AP	2014-09-23	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-10-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2021-01-15	UNKNOWN
LABELING; Labeling	SUPPL	13	AP	2021-01-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-01-15	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-01-15	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-01-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	13	Null	7
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15

TE Codes

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

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91226
            [companyName] => MYLAN PHARMS 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
        )

)