ANDA 089645

HOSPIRA

FDA Drug Application

Application #089645

Application Sponsors

ANDA 089645

HOSPIRA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.005MG/ML;1.5%

0

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-06-21
LABELING; Labeling	SUPPL	2	AP	1990-03-21
LABELING; Labeling	SUPPL	3	AP	1990-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-05-26
LABELING; Labeling	SUPPL	7	AP	2002-01-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-09-03
LABELING; Labeling	SUPPL	17	AP	2010-04-12
LABELING; Labeling	SUPPL	30	AP	2020-07-15	STANDARD
LABELING; Labeling	SUPPL	32	AP	2020-07-15	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	17	Null	7
SUPPL	30	Null	7
SUPPL	32	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89645
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","activeIngredients":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","strength":"0.005MG\/ML;1.5%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","submission":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","actionType":"0.005MG\/ML;1.5%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)