ANDA 201365

SAGENT PHARMS INC

FDA Drug Application

Application #201365

Application Sponsors

ANDA 201365

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/VIAL

0

COLISTIMETHATE SODIUM

COLISTIMETHATE SODIUM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-02-19
LABELING; Labeling	SUPPL	2	AP	2016-02-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-03-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-03-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201365
            [companyName] => SAGENT PHARMS INC
            [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":"02\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/28\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-02-28
        )

)