ANDA 090648

GLAND PHARMA LTD

FDA Drug Application

Application #090648

Documents

• Review: 2013-01-22

Application Sponsors

ANDA 090648

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	2012-06-15
LABELING; Labeling	SUPPL	3	AP	2013-06-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-01-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-01-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-08-18	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-08-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-03-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90648
            [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":"Yes"}]
            [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
        )

)