ANDA 070917

ABBOTT

FDA Drug Application

Application #070917

Application Sponsors

ANDA 070917

ABBOTT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

NALBUPHINE HYDROCHLORIDE

NALBUPHINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1989-02-03
LABELING; Labeling	SUPPL	2	AP	1991-02-28
LABELING; Labeling	SUPPL	3	AP	1996-04-26

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70917
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALBUPHINE HYDROCHLORIDE","activeIngredients":"NALBUPHINE HYDROCHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NALBUPHINE HYDROCHLORIDE","submission":"NALBUPHINE HYDROCHLORIDE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)