NDA 010496

ASTRAZENECA

FDA Drug Application

Application #010496

Application Sponsors

NDA 010496

ASTRAZENECA

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;SPINAL

5%

0

XYLOCAINE 5% W/ GLUCOSE 7.5%

LIDOCAINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1958-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1978-05-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	1979-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-07-07	STANDARD
LABELING; Labeling	SUPPL	9	AP	1982-07-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	1985-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-09-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	1988-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-03-08	STANDARD
LABELING; Labeling	SUPPL	18	AP	1995-04-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	1999-03-12	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10496
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"XYLOCAINE 5% W\/ GLUCOSE 7.5%","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"5%","dosageForm":"INJECTABLE;SPINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"XYLOCAINE 5% W\/ GLUCOSE 7.5%","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"5%","submissionClassification":"INJECTABLE;SPINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)