NDA 014127

ASTRAZENECA

FDA Drug Application

Application #014127

Application Sponsors

NDA 014127

ASTRAZENECA

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;TOPICAL

5%

0

XYLOCAINE

LIDOCAINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1964-03-11	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1985-03-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-03-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-06-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-09-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-02-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-05-31	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 14127
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"XYLOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"XYLOCAINE","submission":"LIDOCAINE","actionType":"5%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)