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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 009395

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NDA 009395 describes PASKALIUM, which is a drug marketed by Glenwood and is included in one NDA. Additional details are available on the PASKALIUM profile page.

The generic ingredient in PASKALIUM is potassium aminosalicylate. There are two hundred and forty drug master file entries for this compound. Additional details are available on the potassium aminosalicylate profile page.

Summary for 009395

Tradename:	PASKALIUM
Applicant:	Glenwood
Ingredient:	potassium aminosalicylate
Patents:	0

Profile for product number 003

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

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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