ANDA 077433

AREVA PHARMS

FDA Drug Application

Application #077433

Application Sponsors

ANDA 077433

AREVA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	30MG/VIAL	0	PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM
002	INJECTABLE;INJECTION	60MG/VIAL	0	PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM
003	INJECTABLE;INJECTION	90MG/VIAL	0	PAMIDRONATE DISODIUM	PAMIDRONATE DISODIUM

FDA Submissions

	ORIG	1	AP	2008-11-26
LABELING; Labeling	SUPPL	2	AP	2016-11-29
LABELING; Labeling	SUPPL	3	AP	2016-11-29

Submissions Property Types

SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001	Prescription	AP
003	Prescription	AP

CDER Filings

AREVA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77433
            [companyName] => AREVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"30MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"60MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"90MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"30MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"60MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"90MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)