ANDA 203704

QILU

FDA Drug Application

Application #203704

Application Sponsors

ANDA 203704

QILU

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-01
LABELING; Labeling	SUPPL	2	AP	2017-08-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-08-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-11	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-01-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	15
SUPPL	7	Null	7
SUPPL	14	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203704
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/01\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/11\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/15\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/15\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-11
        )

)