ANDA 078945

EMCURE PHARMS LTD

FDA Drug Application

Application #078945

Application Sponsors

ANDA 078945

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2013-01-03
LABELING; Labeling	SUPPL	5	AP	2015-01-14	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-01-14	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-08-18	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-08-18	STANDARD
LABELING; Labeling	SUPPL	20	AP	2023-01-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7
SUPPL	8	Null	15
SUPPL	14	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	7

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78945
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)