NDA 016012

TEVA WOMENS

FDA Drug Application

Application #016012

Documents

• Letter: 2014-07-21
• Other Important Information from FDA: 2007-05-09
• Medication Guide: 2018-02-28

Application Sponsors

NDA 016012

TEVA WOMENS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	VIVACTIL	PROTRIPTYLINE HYDROCHLORIDE
002	TABLET;ORAL	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	VIVACTIL	PROTRIPTYLINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1967-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1977-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1978-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1980-01-29	STANDARD
LABELING; Labeling	SUPPL	27	AP	1980-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1981-03-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1981-03-10	STANDARD
LABELING; Labeling	SUPPL	30	AP	1981-03-06
LABELING; Labeling	SUPPL	32	AP	1982-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1983-06-09	STANDARD
LABELING; Labeling	SUPPL	35	AP	1984-07-16
LABELING; Labeling	SUPPL	36	AP	1985-09-20
LABELING; Labeling	SUPPL	37	AP	1986-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1988-03-18	STANDARD
LABELING; Labeling	SUPPL	40	AP	1987-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1988-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1993-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1994-06-01	STANDARD
LABELING; Labeling	SUPPL	44	AP	2000-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1996-04-15	STANDARD
LABELING; Labeling	SUPPL	46	AP	2000-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1996-12-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1997-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1998-11-04	STANDARD
LABELING; Labeling	SUPPL	50	AP	2000-04-11	STANDARD
LABELING; Labeling	SUPPL	51	AP	2000-04-11	STANDARD
LABELING; Labeling	SUPPL	52	AP	2000-04-11	STANDARD
LABELING; Labeling	SUPPL	53	AP	2014-07-17	901 REQUIRED

Submissions Property Types

SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	34	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	53	Null	6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16012
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)