ANDA 063000

XGEN PHARMS

FDA Drug Application

Application #063000

Application Sponsors

ANDA 063000

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500,000 UNITS BASE/VIAL

0

POLYMYXIN B SULFATE

POLYMYXIN B SULFATE

FDA Submissions

	ORIG	1	AP	1994-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-01-16
LABELING; Labeling	SUPPL	5	AP	1998-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-11-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

TE Codes

001

Prescription

AP

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 63000
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"POLYMYXIN B SULFATE","activeIngredients":"POLYMYXIN B SULFATE","strength":"EQ 500,000 UNITS BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POLYMYXIN B SULFATE","submission":"POLYMYXIN B SULFATE","actionType":"EQ 500,000 UNITS BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)