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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 012359

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NDA 012359 describes SALUTENSIN-DEMI, which is a drug marketed by Shire and is included in one NDA. Additional details are available on the SALUTENSIN-DEMI profile page.

The generic ingredient in SALUTENSIN-DEMI is hydroflumethiazide; reserpine. There are two drug master file entries for this compound. Additional details are available on the hydroflumethiazide; reserpine profile page.

Summary for 012359

Tradename:	SALUTENSIN-DEMI
Applicant:	Shire
Ingredient:	hydroflumethiazide; reserpine
Patents:	0

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG;0.125MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;0.125MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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