ANDA 077269

PHARMACHEMIE BV

FDA Drug Application

Application #077269

Documents

• Letter: 2004-10-18

Application Sponsors

ANDA 077269

PHARMACHEMIE BV

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INTRAVENOUS	50MG/5ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN
002	INJECTABLE;INTRAVENOUS	150MG/15ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN
003	INJECTABLE;INTRAVENOUS	450MG/45ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN
004	INJECTABLE;INTRAVENOUS	600MG/60ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN

FDA Submissions

	ORIG	1	AP	2004-10-14
LABELING; Labeling	SUPPL	2	AP	2007-12-28
LABELING; Labeling	SUPPL	8	AP	2012-03-26

Submissions Property Types

ORIG	1	Null	1
SUPPL	8	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

PHARMACHEMIE BV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77269
            [companyName] => PHARMACHEMIE BV
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"150MG\/15ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"450MG\/45ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"600MG\/60ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"50MG\/5ML (10MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"150MG\/15ML (10MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"450MG\/45ML (10MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"600MG\/60ML (10MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)