Details for New Drug Application (NDA): 018201

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NDA 018201 describes MODURETIC 5-50, which is a drug marketed by Merck and is included in one NDA. Additional details are available on the MODURETIC 5-50 profile page.

The generic ingredient in MODURETIC 5-50 is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.

Summary for 018201

Tradename:	MODURETIC 5-50
Applicant:	Merck
Ingredient:	amiloride hydrochloride; hydrochlorothiazide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG ANHYDROUS;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018201

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	MODURETIC 5-50	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	018201-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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