ANDA 207146

WOCKHARDT BIO AG

FDA Drug Application

Application #207146

Application Sponsors

ANDA 207146

WOCKHARDT BIO AG

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	2017-03-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-10-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

WOCKHARDT BIO AG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207146
            [companyName] => WOCKHARDT BIO AG
            [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":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/26\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-10-26
        )

)