ANDA 206996

WOCKHARDT BIO AG

FDA Drug Application

Application #206996

Application Sponsors

ANDA 206996

WOCKHARDT BIO AG

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	2017-03-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

WOCKHARDT BIO AG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206996
            [companyName] => WOCKHARDT BIO AG
            [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":"Yes"},{"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":"Yes"},{"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":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/22\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-12-22
        )

)