ANDA 091493

SAGENT PHARMS INC

FDA Drug Application

Application #091493

Application Sponsors

ANDA 091493

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

	ORIG	1	AP	2014-11-24
LABELING; Labeling	SUPPL	4	AP	2015-09-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-12-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-12-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-12-21	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-12-21	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91493
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)