ANDA 203454

MYLAN LABS LTD

FDA Drug Application

Application #203454

Application Sponsors

ANDA 203454

MYLAN LABS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	0	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	0	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-04-04

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203454
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/04\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-04
        )

)