ANDA 090970

MYLAN PHARMS INC

FDA Drug Application

Application #090970

Application Sponsors

ANDA 090970

MYLAN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	0	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM
002	TABLET, DELAYED RELEASE;ORAL	EQ 40MG BASE	0	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM

FDA Submissions

	ORIG	1	AP	2011-01-19
LABELING; Labeling	SUPPL	2	AP	2012-01-11
LABELING; Labeling	SUPPL	3	AP	2012-09-07
LABELING; Labeling	SUPPL	6	AP	2013-08-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-04-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-04-08	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-09-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-09-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-09-16	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-09-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-09-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90970
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 20MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 40MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)