ANDA 077761

HIKMA FARMACEUTICA

FDA Drug Application

Application #077761

Application Sponsors

ANDA 077761

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

METOPROLOL TARTRATE

METOPROLOL TARTRATE

FDA Submissions

	ORIG	1	AP	2007-05-30
LABELING; Labeling	SUPPL	6	AP	2009-02-26
LABELING; Labeling	SUPPL	9	AP	2010-01-19
LABELING; Labeling	SUPPL	10	AP	2010-02-26
LABELING; Labeling	SUPPL	13	AP	2013-02-27
LABELING; Labeling	SUPPL	16	AP	2015-11-12	STANDARD
LABELING; Labeling	SUPPL	24	AP	2022-01-07	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	7
SUPPL	16	Null	15
SUPPL	24	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77761
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)