NDA 020668

ASTRAZENECA

FDA Drug Application

Application #020668

Documents

• Letter: 1998-10-28
• Letter: 2005-08-04
• Letter: 2003-06-22
• Letter: 2004-12-29
• Letter: 2007-10-10
• Label: 2005-08-04
• Label: 2004-06-10
• Review: 2007-07-06
• Review: 2002-07-25
• Review: 2008-02-19
• Letter: 2004-06-10
• Label: 1998-10-28
• Review: 2007-07-06

Application Sponsors

NDA 020668

ASTRAZENECA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG;5MG	0	LEXXEL	ENALAPRIL MALEATE; FELODIPINE
002	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG	0	LEXXEL	ENALAPRIL MALEATE; FELODIPINE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1996-12-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	1998-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-10-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	1998-07-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2005-08-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2000-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-02-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2001-09-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2003-06-11	STANDARD
LABELING; Labeling	SUPPL	11	AP	2004-06-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	2004-12-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2007-10-04	STANDARD

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
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20668
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEXXEL","activeIngredients":"ENALAPRIL MALEATE; FELODIPINE","strength":"5MG;5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEXXEL","activeIngredients":"ENALAPRIL MALEATE; FELODIPINE","strength":"5MG;2.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/02\/2005","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020668s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2004","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20668slr011_lexxel_lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/1998","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/20-668S003_Lexxel_prntlbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"LEXXEL","submission":"ENALAPRIL MALEATE; FELODIPINE","actionType":"5MG;5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEXXEL","submission":"ENALAPRIL MALEATE; FELODIPINE","actionType":"5MG;2.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-08-02
        )

)