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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 087318

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NDA 087318 describes TOLBUTAMIDE, which is a drug marketed by Alra, Ani Pharms, Ascot, Barr, Chartwell Rx, Dava Pharms Inc, Norvium Bioscience, Parke Davis, 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 087318

Tradename:	TOLBUTAMIDE
Applicant:	Watson Labs
Ingredient:	tolbutamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 087318

Hypoglycemic Agents

Profile for product number 001

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

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