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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 084442

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NDA 084442 describes PROBENECID, which is a drug marketed by Aurobindo Pharma Usa, Ivax Sub Teva Pharms, Lederle, Rising, Watson Labs, Watson Labs Teva, Ani Pharms, Beecham, Impax Labs, Novast Labs, and Sandoz, and is included in fourteen NDAs. It is available from three suppliers. Additional details are available on the PROBENECID profile page.

The generic ingredient in PROBENECID is colchicine; probenecid. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the colchicine; probenecid profile page.

Summary for 084442

Tradename:	PROBENECID
Applicant:	Watson Labs Teva
Ingredient:	probenecid
Patents:	0

Medical Subject Heading (MeSH) Categories for 084442

Adjuvants, Pharmaceutic
Uricosuric Agents

Suppliers and Packaging for NDA: 084442

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROBENECID	probenecid	TABLET;ORAL	084442	ANDA	Actavis Pharma, Inc.	0591-5347	0591-5347-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-01)
PROBENECID	probenecid	TABLET;ORAL	084442	ANDA	Actavis Pharma, Inc.	0591-5347	0591-5347-10	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-10)

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Mar 29, 1983	TE:	AB	RLD:	No

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