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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 088893

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NDA 088893 describes TOLBUTAMIDE, which is a drug marketed by Alra, Ani Pharms, Ascot, Barr, Chartwell Rx, Dava Pharms Inc, Parke Davis, Pharmobedient, Purepac Pharm, Sandoz, Superpharm, Vangard, and Watson Labs, and is included in sixteen NDAs. Additional details are available on the TOLBUTAMIDE profile page.

The generic ingredient in TOLBUTAMIDE is tolbutamide. There are fifteen drug master file entries for this compound. Additional details are available on the tolbutamide profile page.

Summary for 088893

Tradename:	TOLBUTAMIDE
Applicant:	Superpharm
Ingredient:	tolbutamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 088893

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 19, 1984	TE:		RLD:	No

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