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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 018894

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NDA 018894 describes TOLAZAMIDE, which is a drug marketed by Barr, Chartwell Rx, Cosette, Duramed Pharms Barr, Interpharm, Natco, Par Pharm, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in thirty NDAs. Additional details are available on the TOLAZAMIDE profile page.

The generic ingredient in TOLAZAMIDE is tolazamide. There are six drug master file entries for this compound. Additional details are available on the tolazamide profile page.

Summary for 018894

Tradename:	TOLAZAMIDE
Applicant:	Cosette
Ingredient:	tolazamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 018894

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Nov 2, 1984	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Nov 2, 1984	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 2, 1984	TE:		RLD:	No

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