ANDA 078247

HIKMA FARMACEUTICA

FDA Drug Application

Application #078247

Application Sponsors

ANDA 078247

HIKMA FARMACEUTICA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE

FDA Submissions

	ORIG	1	AP	2009-04-29
LABELING; Labeling	SUPPL	2	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-09-15	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78247
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTORPHANOL TARTRATE","activeIngredients":"BUTORPHANOL TARTRATE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTORPHANOL TARTRATE","submission":"BUTORPHANOL TARTRATE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)