ANDA 076781

HIKMA FARMACEUTICA

FDA Drug Application

Application #076781

Application Sponsors

ANDA 076781

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-12-26
LABELING; Labeling	SUPPL	7	AP	2011-01-31
LABELING; Labeling	SUPPL	9	AP	2012-04-30
LABELING; Labeling	SUPPL	10	AP	2013-09-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-12-20	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-12-20	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76781
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)