ANDA 079224

GLAND PHARMA LTD

FDA Drug Application

Application #079224

Application Sponsors

ANDA 079224

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-09-25
LABELING; Labeling	SUPPL	2	AP	2013-06-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2013-06-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-01-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-01-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-08-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-08-18	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-03-11	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	11	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79224
            [companyName] => GLAND PHARMA LTD
            [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
        )

)