ANDA 203720

FRESENIUS KABI

FDA Drug Application

Application #203720

Application Sponsors

ANDA 203720

FRESENIUS KABI

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

0

PIPERACILLIN AND TAZOBACTAM

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-11
LABELING; Labeling	SUPPL	3	AP	2021-05-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203720
            [companyName] => FRESENIUS KABI
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 36GM BASE\/VIAL;EQ 4.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-11
        )

)