ANDA 203719

FRESENIUS KABI

FDA Drug Application

Application #203719

Application Sponsors

ANDA 203719

FRESENIUS KABI

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	0	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
002	INJECTABLE;INJECTION	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	0	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
003	INJECTABLE;INJECTION	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	0	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-18
LABELING; Labeling	SUPPL	3	AP	2021-02-18	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

FRESENIUS KABI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203719
            [companyName] => FRESENIUS KABI
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 2GM BASE\/VIAL;EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 3GM BASE\/VIAL;EQ 375MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 4GM BASE\/VIAL;EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-18
        )

)