NDA 019058

ASTRAZENECA

FDA Drug Application

Application #019058

Documents

• Letter: 2003-01-22
• Letter: 2005-02-11
• Letter: 2003-11-13
• Review: 2001-06-04
• Review: 2001-06-04

Application Sponsors

NDA 019058

ASTRAZENECA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

TENORMIN

ATENOLOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-09-13	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1991-04-05	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1991-04-17	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1991-09-18	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1992-08-05	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1992-08-05	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1993-04-29	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1994-05-04	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1996-03-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-02-05	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2000-04-04	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1999-07-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-10-19	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2003-01-22	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2003-11-06	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2005-02-09	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
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19058
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENORMIN","activeIngredients":"ATENOLOL","strength":"0.5MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TENORMIN","submission":"ATENOLOL","actionType":"0.5MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)