ANDA 202235

SAGENT PHARMS INC

FDA Drug Application

Application #202235

Application Sponsors

ANDA 202235

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 3MG BASE/3ML

0

IBANDRONATE SODIUM

IBANDRONATE SODIUM

FDA Submissions

	ORIG	1	AP	2014-09-02
LABELING; Labeling	SUPPL	3	AP	2019-12-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202235
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 3MG BASE\/3ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-13
        )

)