ANDA 074227

PHARMACHEMIE BV

FDA Drug Application

Application #074227

Application Sponsors

ANDA 074227

PHARMACHEMIE BV

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

ETOPOSIDE

ETOPOSIDE

FDA Submissions

	ORIG	1	AP	1996-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-07-16

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0

CDER Filings

PHARMACHEMIE BV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74227
            [companyName] => PHARMACHEMIE BV
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETOPOSIDE","activeIngredients":"ETOPOSIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ETOPOSIDE","submission":"ETOPOSIDE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)