Details for New Drug Application (NDA): 200797

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NDA 200797 describes AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo Pharma, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma Intl, Teva Pharms, and Torrent, and is included in six NDAs. It is available from four suppliers. Additional details are available on the AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Tradename:	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Applicant:	Lupin Ltd
Ingredient:	amlodipine besylate; hydrochlorothiazide; valsartan
Patents:	0

Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;12.5MG;160MG
Approval Date:	Jun 3, 2015	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;25MG;160MG
Approval Date:	Jun 3, 2015	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;12.5MG;160MG
Approval Date:	Jun 3, 2015	TE:	AB	RLD:	No

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