ANDA 074656

PHARMACHEMIE BV

FDA Drug Application

Application #074656

Documents

• Letter: 2000-05-16

Application Sponsors

ANDA 074656

PHARMACHEMIE BV

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

CISPLATIN

CISPLATIN

FDA Submissions

	ORIG	1	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-07-01
LABELING; Labeling	SUPPL	6	AP	2008-10-17
LABELING; Labeling	SUPPL	10	AP	2012-01-23
LABELING; Labeling	SUPPL	12	AP	2012-03-15
LABELING; Labeling	SUPPL	15	AP	2015-09-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

PHARMACHEMIE BV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74656
            [companyName] => PHARMACHEMIE BV
            [docInserts] => ["",""]
            [products] => [{"drugName":"CISPLATIN","activeIngredients":"CISPLATIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CISPLATIN","submission":"CISPLATIN","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)