ANDA 063206

XGEN PHARMS

FDA Drug Application

Application #063206

Application Sponsors

ANDA 063206

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/VIAL

0

AMPHOTERICIN B

AMPHOTERICIN B

FDA Submissions

	ORIG	1	AP	1992-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-01-17
LABELING; Labeling	SUPPL	3	AP	1995-03-15
LABELING; Labeling	SUPPL	4	AP	1996-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-09-18
LABELING; Labeling	SUPPL	6	AP	1999-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-02-11
LABELING; Labeling	SUPPL	16	AP	2009-02-17
LABELING; Labeling	SUPPL	17	AP	2010-03-05

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	17	Null	7

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 63206
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHOTERICIN B","activeIngredients":"AMPHOTERICIN B","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMPHOTERICIN B","submission":"AMPHOTERICIN B","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)