ANDA 065177

NEXUS PHARMS

FDA Drug Application

Application #065177

Documents

• Other Important Information from FDA: 2007-06-29

Application Sponsors

ANDA 065177

NEXUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/VIAL

0

COLISTIMETHATE SODIUM

COLISTIMETHATE SODIUM

FDA Submissions

	ORIG	1	AP	2004-03-19
LABELING; Labeling	SUPPL	12	AP	2015-08-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-09-20	STANDARD

Submissions Property Types

SUPPL	12	Null	15
SUPPL	15	Null	7

TE Codes

001

Prescription

AP

CDER Filings

NEXUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65177
            [companyName] => NEXUS 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
        )

)