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AstraZeneca
Chubb
Harvard Business School
QuintilesIMS
Medtronic
Healthtrust
Dow
Daiichi Sankyo
Julphar

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040862

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NDA 040862 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 040862
Tradename:PRIMIDONE
Applicant:Dr Reddys Labs Ltd
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040862
Medical Subject Heading (MeSH) Categories for 040862
Suppliers and Packaging for NDA: 040862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMIDONE primidone TABLET;ORAL 040862 ANDA Dr. Reddy's Laboratories Limited 55111-476 N 55111-476-01
PRIMIDONE primidone TABLET;ORAL 040862 ANDA Dr. Reddy's Laboratories Limited 55111-476 N 55111-476-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Oct 3, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Oct 3, 2008TE:RLD:No

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McKinsey
McKesson
Chinese Patent Office
Fuji
Mallinckrodt
Fish and Richardson
Covington
US Army
Federal Trade Commission

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