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Cantor Fitzgerald
Baxter
Farmers Insurance
US Department of Justice
Johnson and Johnson
McKesson
Cipla
Cerilliant
Accenture

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084903

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NDA 084903 describes PRIMIDONE, which is a drug marketed by Amneal Pharm, Anda Repository, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Vintage Pharms, and Watson Labs, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the PRIMIDONE profile page.

The generic ingredient in PRIMIDONE is primidone. There are seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the primidone profile page.
Summary for 084903
Tradename:PRIMIDONE
Applicant:Lannett
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 084903
Medical Subject Heading (MeSH) Categories for 084903
Suppliers and Packaging for NDA: 084903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMIDONE primidone TABLET;ORAL 084903 ANDA Lannett Company, Inc. 0527-1231 N 0527-1231-01
PRIMIDONE primidone TABLET;ORAL 084903 ANDA Lannett Company, Inc. 0527-1231 N 0527-1231-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 24, 2001TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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UBS
Dow
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Federal Trade Commission
McKesson
Merck
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