Application 206180

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	No	No
002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	No	No
003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	No	No
004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	No	No
005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65862-834	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-834	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-834	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-834	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-834	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-835	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-835	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-835	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-835	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-835	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-836	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-836	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-836	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-836	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-836	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-837	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-837	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-837	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-837	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-837	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-838	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-838	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-838	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-838	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-838	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current

Application 206180

Related Records#

Application Products#

NDC Listings For This Application#