ANDA 090763

MYLAN PHARMS INC

FDA Drug Application

Application #090763

Documents

• Letter: 2009-11-19

Application Sponsors

ANDA 090763

MYLAN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	0	LANSOPRAZOLE	LANSOPRAZOLE
002	CAPSULE, DELAYED REL PELLETS;ORAL	30MG	0	LANSOPRAZOLE	LANSOPRAZOLE

FDA Submissions

	ORIG	1	AP	2009-11-10
LABELING; Labeling	SUPPL	2	AP	2012-08-28
LABELING; Labeling	SUPPL	3	AP	2012-08-28
LABELING; Labeling	SUPPL	4	AP	2013-08-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-03-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90763
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LANSOPRAZOLE","submission":"LANSOPRAZOLE","actionType":"15MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LANSOPRAZOLE","submission":"LANSOPRAZOLE","actionType":"30MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)