ANDA 079183

HOSPIRA INC

FDA Drug Application

Application #079183

Documents

• Letter: 2009-02-24

Application Sponsors

ANDA 079183

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2GM BASE/VIAL

0

GEMCITABINE HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-11-15
LABELING; Labeling	SUPPL	4	AP	2016-11-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-11-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-10-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79183
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GEMCITABINE HYDROCHLORIDE","submission":"GEMCITABINE HYDROCHLORIDE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)