ANDA 203711

QILU

FDA Drug Application

Application #203711

Documents

• Letter: 2014-09-10
• Label: 2014-09-23

Application Sponsors

ANDA 203711

QILU

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-09-08
LABELING; Labeling	SUPPL	2	AP	2021-09-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-09-01	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-02-28	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	15

TE Codes

001

Prescription

AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203711
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/08\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203711Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/08\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203711Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203711Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/03\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-04-03
        )

)