ANDA 088571

HOSPIRA

FDA Drug Application

Application #088571

Application Sponsors

ANDA 088571

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	1985-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-05-10
LABELING; Labeling	SUPPL	5	AP	1991-02-15
LABELING; Labeling	SUPPL	6	AP	2002-12-27
LABELING; Labeling	SUPPL	7	AP	2002-01-02
LABELING; Labeling	SUPPL	17	AP	2010-04-09
LABELING; Labeling	SUPPL	28	AP	2020-07-15	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-07-15	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	17	Null	7
SUPPL	28	Null	15
SUPPL	30	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88571
            [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
        )

)