ANDA 203661

QILU

FDA Drug Application

Application #203661

Application Sponsors

ANDA 203661

QILU

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM
002	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-28
LABELING; Labeling	SUPPL	6	AP	2022-02-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203661
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-28
        )

)