ANDA 209218

QILU

FDA Drug Application

Application #209218

Application Sponsors

ANDA 209218

QILU

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

CEFTRIAXONE

CEFTRIAXONE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209218
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-17
        )

)