ANDA 203702

QILU

FDA Drug Application

Application #203702

Application Sponsors

ANDA 203702

QILU

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 250MG BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM
002	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 500MG BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM
003	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM
004	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 2GM BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-29
LABELING; Labeling	SUPPL	4	AP	2020-08-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	8	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203702
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/07\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-07
        )

)