ANDA 064216

XGEN PHARMS

FDA Drug Application

Application #064216

Documents

• Letter: 1999-02-26
• Review: 2012-06-27
• Other Important Information from FDA: 2007-06-29

Application Sponsors

ANDA 064216

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/VIAL

0

COLISTIMETHATE SODIUM

COLISTIMETHATE SODIUM

FDA Submissions

	ORIG	1	AP	1999-02-26
LABELING; Labeling	SUPPL	3	AP	2001-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-02-01
LABELING; Labeling	SUPPL	6	AP	2006-02-07
LABELING; Labeling	SUPPL	8	AP	2006-07-03
LABELING; Labeling	SUPPL	11	AP	2011-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2018-06-06	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64216
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLISTIMETHATE SODIUM","activeIngredients":"COLISTIMETHATE SODIUM","strength":"EQ 150MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COLISTIMETHATE SODIUM","submission":"COLISTIMETHATE SODIUM","actionType":"EQ 150MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)