NDA 020962

ASTRAZENECA

FDA Drug Application

Application #020962

Documents

• Review: 1998-02-04

Application Sponsors

NDA 020962

ASTRAZENECA

Marketing Status

• Discontinued: 001

Application Products

001

DISC;TOPICAL

2.5%;2.5%

0

EMLA

LIDOCAINE; PRILOCAINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-02-15	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20962
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMLA","activeIngredients":"LIDOCAINE; PRILOCAINE","strength":"2.5%;2.5%","dosageForm":"DISC;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EMLA","submission":"LIDOCAINE; PRILOCAINE","actionType":"2.5%;2.5%","submissionClassification":"DISC;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)