ANDA 088329

HOSPIRA

FDA Drug Application

Application #088329

Application Sponsors

ANDA 088329

HOSPIRA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1%

0

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-08-15
LABELING; Labeling	SUPPL	3	AP	1988-12-23
LABELING; Labeling	SUPPL	4	AP	1991-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-01-07
LABELING; Labeling	SUPPL	16	AP	2000-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-10-25
LABELING; Labeling	SUPPL	28	AP	2010-04-16
LABELING; Labeling	SUPPL	40	AP	2020-03-19	STANDARD
LABELING; Labeling	SUPPL	41	AP	2020-03-19	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	28	Null	7
SUPPL	40	Null	7
SUPPL	41	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88329
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"1%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"1%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)