ANDA 088328

HOSPIRA

FDA Drug Application

Application #088328

Application Sponsors

ANDA 088328

HOSPIRA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.5%

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	1988-12-12
LABELING; Labeling	SUPPL	4	AP	1990-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-10-03
LABELING; Labeling	SUPPL	17	AP	2010-04-16
LABELING; Labeling	SUPPL	29	AP	2020-03-19	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-03-19	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	17	Null	7
SUPPL	29	Null	15
SUPPL	30	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88328
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"0.5%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)