ANDA 208580

MYLAN LABS LTD

FDA Drug Application

Application #208580

Application Sponsors

ANDA 208580

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;IV (INFUSION)

EQ 40MG BASE/VIAL

0

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-04-08	STANDARD

Submissions Property Types

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

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208580
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-04
        )

)