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Generated: December 15, 2018

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Details for New Drug Application (NDA): 084211

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NDA 084211 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, Novast Labs, and Sandoz, and is included in twelve NDAs. It is available from six 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 084211
Tradename:PROBENECID
Applicant:Mylan
Ingredient:probenecid
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084211
Suppliers and Packaging for NDA: 084211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROBENECID probenecid TABLET;ORAL 084211 ANDA Mylan Pharmaceuticals Inc. 0378-0156 0378-0156-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0156-01)
PROBENECID probenecid TABLET;ORAL 084211 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-991 43353-991-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-991-60)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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