Application 071196

Type: ANDA
Sponsor: APOTEX INC

Related Records

Company: APOTEX INC

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	100MG	No	Yes
002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0711	Trazodone Hydrochloride	Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0711	Trazodone Hydrochloride	Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0733	Trazodone Hydrochloride	Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0733	Trazodone Hydrochloride	Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0733	Trazodone Hydrochloride	Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0733	Trazodone Hydrochloride	Trazodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0904-6555	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6555	Trazodone Hydrochloride	Trazodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
10544-867	Trazodone Hydrochloride	Trazodone Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
50090-2373	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2373	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2373	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2373	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2373	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2373	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2374	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2374	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2374	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2374	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2374	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2759	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-771	Trazodone Hydrochloride	Trazodone Hydrochloride	AvPAK	ANDA	Current
55154-7642	Trazodone Hydrochloride	Trazodone Hydrochloride	Cardinal Health	ANDA	Current
55154-7642	Trazodone Hydrochloride	Trazodone Hydrochloride	Cardinal Health	ANDA	Current
55700-645	Trazodone Hydrochloride	Trazodone Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60429-188	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-188	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-188	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-188	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-230	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-230	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-230	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-230	Trazodone Hydrochloride	Trazodone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60505-2654	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2654	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2654	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2654	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2655	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2655	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2655	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2655	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2659	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2659	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2659	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-2659	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-4089	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-4089	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-4089	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
60505-4089	Trazodone Hydrochloride	Trazodone Hydrochloride	Apotex Corp	ANDA	Current
63629-7287	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7287	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7287	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-3256	Trazodone Hydrochloride	Trazodone Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68084-608	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
68084-608	Trazodone Hydrochloride	Trazodone Hydrochloride	American Health Packaging	ANDA	Current
68788-7004	Trazodone Hydrochloride	Trazodone Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7004	Trazodone Hydrochloride	Trazodone Hydrochloride	Preferred Pharmaceuticals	ANDA	Current
70518-1195	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1195	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3403	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0164	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0164	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0343	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0343	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0773	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0773	Trazodone Hydrochloride	Trazodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-513	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents

Document	Submission type	Date
53958	ORIG	2018-05-01
47233	SUPPL	2017-02-16
47232	SUPPL	2017-02-16
39428	SUPPL	2013-11-20
8404	SUPPL	2013-11-20