Details for New Drug Application (NDA): 001546

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NDA 001546 describes GUANIDINE HYDROCHLORIDE, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. Additional details are available on the GUANIDINE HYDROCHLORIDE profile page.

The generic ingredient in GUANIDINE HYDROCHLORIDE is guanidine hydrochloride. There are eight drug master file entries for this compound. Additional details are available on the guanidine hydrochloride profile page.

Summary for 001546

Tradename:	GUANIDINE HYDROCHLORIDE
Applicant:	Merck Sharp Dohme
Ingredient:	guanidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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