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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084442

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NDA 084442 describes PROBENECID, which is a drug marketed by Ivax Sub Teva Pharms, Lederle, Mylan, Watson Labs, Watson Labs Teva, Ani Pharms Inc, Beecham, Impax Labs, Ingenus Pharms Nj, and Sandoz, and is included in twelve NDAs. It is available from seven 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. Two suppliers are listed for this compound. Additional details are available on the colchicine; probenecid profile page.
Summary for 084442
Applicant:Watson Labs Teva
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084442
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 N 0591-5347-01
PROBENECID probenecid TABLET;ORAL 084442 ANDA Actavis Pharma, Inc. 0591-5347 N 0591-5347-10

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 29, 1983TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health

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