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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 086113

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NDA 086113 describes GUANETHIDINE MONOSULFATE, which is a drug marketed by Watson Labs and is included in two NDAs. Additional details are available on the GUANETHIDINE MONOSULFATE profile page.

The generic ingredient in GUANETHIDINE MONOSULFATE is guanethidine monosulfate. There are two drug master file entries for this compound. Additional details are available on the guanethidine monosulfate profile page.

Summary for 086113

Tradename:	GUANETHIDINE MONOSULFATE
Applicant:	Watson Labs
Ingredient:	guanethidine monosulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 086113

Adrenergic Agents
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG SULFATE
Approval Date:	Mar 26, 1985	TE:		RLD:	No

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