Last Updated: November 13, 2026

Details for New Drug Application (NDA): 071358

NDA 071358 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 is one drug master file entry for this compound. Additional details are available on the tolazamide profile page.

Summary for 071358

Tradename:	TOLAZAMIDE
Applicant:	Sun Pharm Industries
Ingredient:	tolazamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 071358

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jul 16, 1987	TE:		RLD:	No

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