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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 080966

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NDA 080966 describes PROBALAN, which is a drug marketed by Lannett and is included in one NDA. It is available from two suppliers. Additional details are available on the PROBALAN profile page.

The generic ingredient in PROBALAN is probenecid. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the probenecid profile page.
Summary for 080966
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 080966
Suppliers and Packaging for NDA: 080966
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROBALAN probenecid TABLET;ORAL 080966 ANDA Lannett Company, Inc. 0527-1367 0527-1367-01 100 TABLET, FILM COATED in 1 BOTTLE (0527-1367-01)
PROBALAN probenecid TABLET;ORAL 080966 ANDA Lannett Company, Inc. 0527-1367 0527-1367-10 1000 TABLET, FILM COATED in 1 BOTTLE (0527-1367-10)

Profile for product number 001

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

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