Application 091154

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;20MG	No	No
002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;40MG	No	No
003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;20MG	No	No
004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;40MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7027	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7027	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7028	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7028	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7029	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7029	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7030	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7030	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	ANDA	Current
45865-901	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	medsource pharmaceuticals	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
45700	ORIG	2016-10-28
9322	ORIG	2015-10-21