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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 Mylan, Lederle, Ivax Sub Teva Pharms, Watson Labs, Ingenus Pharms Nj, Impax Labs, Beecham, Sandoz, and Ani Pharms Inc, 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 fifteen 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 NDA: 084211

Therapeutic Class:Antigout Agents

Suppliers and Packaging for NDA: 084211

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 084211 ANDA Mylan Pharmaceuticals Inc. 0378-0156 0378-0156-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0156-01)
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)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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