ANDA 078942

AM REGENT

FDA Drug Application

Application #078942

Documents

• Other Important Information from FDA: 2008-09-19

Application Sponsors

ANDA 078942

AM REGENT

Marketing Status

• Discontinued: 001
• Discontinued: 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	2008-07-25
LABELING; Labeling	SUPPL	3	AP	2012-05-17
LABELING; Labeling	SUPPL	5	AP	2015-10-30	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	5	Null	15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78942
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"30MG\/10ML (3MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"90MG\/10ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"30MG\/10ML (3MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"90MG\/10ML (9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)