ANDA 065386

HOSPIRA INC

FDA Drug Application

Application #065386

Documents

• Letter: 2009-09-22
• Label: 2009-10-01

Application Sponsors

ANDA 065386

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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

	ORIG	1	AP	2009-09-15
LABELING; Labeling	SUPPL	3	AP	2017-10-23
LABELING; Labeling	SUPPL	7	AP	2017-10-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-10-23	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-10-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-10-23	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-10-23	STANDARD

Submissions Property Types

ORIG	1	Null	3
SUPPL	3	Null	7
SUPPL	7	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65386
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 2GM BASE\/VIAL;EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","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":"Discontinued","te":"None","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":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/15\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/065386lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PIPERACILLIN AND TAZOBACTAM","submission":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","actionType":"EQ 2GM BASE\/VIAL;EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PIPERACILLIN AND TAZOBACTAM","submission":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","actionType":"EQ 3GM BASE\/VIAL;EQ 375MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PIPERACILLIN AND TAZOBACTAM","submission":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","actionType":"EQ 4GM BASE\/VIAL;EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-09-15
        )

)