ANDA 090913

SAGENT PHARMS INC

FDA Drug Application

Application #090913

Application Sponsors

ANDA 090913

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

100MG/ML

0

MESNA

MESNA

FDA Submissions

	ORIG	1	AP	2010-04-13
LABELING; Labeling	SUPPL	4	AP	2015-08-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-12-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90913
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESNA","activeIngredients":"MESNA","strength":"100MG\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MESNA","submission":"MESNA","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)