NDA 012704

ASTRAZENECA

FDA Drug Application

Application #012704

Documents

• Letter: 2001-03-27
• Letter: 2003-08-06
• Other Important Information from FDA: 2007-05-09

Application Sponsors

NDA 012704

ASTRAZENECA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

ELAVIL

AMITRIPTYLINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1961-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1981-03-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	1980-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1981-03-02	STANDARD
LABELING; Labeling	SUPPL	22	AP	1980-06-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	1980-09-03	STANDARD
LABELING; Labeling	SUPPL	24	AP	1981-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1981-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1995-10-02	STANDARD
LABELING; Labeling	SUPPL	28	AP	1984-05-21	STANDARD
LABELING; Labeling	SUPPL	30	AP	1983-03-15	STANDARD
LABELING; Labeling	SUPPL	31	AP	1985-09-20	STANDARD
LABELING; Labeling	SUPPL	32	AP	1986-07-10	STANDARD
LABELING; Labeling	SUPPL	33	AP	1991-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1988-12-12	STANDARD
LABELING; Labeling	SUPPL	35	AP	1991-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1989-07-28	STANDARD
LABELING; Labeling	SUPPL	39	AP	2000-04-05	STANDARD
LABELING; Labeling	SUPPL	40	AP	2000-04-05	STANDARD
LABELING; Labeling	SUPPL	41	AP	2000-04-05	STANDARD
LABELING; Labeling	SUPPL	42	AP	2000-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1998-12-24	STANDARD
LABELING; Labeling	SUPPL	44	AP	2000-04-05	STANDARD
LABELING; Labeling	SUPPL	45	AP	2001-03-27	STANDARD
LABELING; Labeling	SUPPL	46	AP	2003-07-29	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12704
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELAVIL","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ELAVIL","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)