ANDA 078373

SAGENT PHARMS INC

FDA Drug Application

Application #078373

Application Sponsors

ANDA 078373

SAGENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	30MG/10ML (3MG/ML)	0	PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM
002	INJECTABLE;INJECTION	90MG/10ML (9MG/ML)	0	PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM

FDA Submissions

	ORIG	1	AP	2008-12-23
LABELING; Labeling	SUPPL	4	AP	2010-03-15
LABELING; Labeling	SUPPL	5	AP	2019-11-22	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	5	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78373
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"30MG\/10ML (3MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"90MG\/10ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"30MG\/10ML (3MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"90MG\/10ML (9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)