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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Army
Harvard Business School
AstraZeneca
Chinese Patent Office
Cantor Fitzgerald
McKinsey
Citi
Deloitte

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083551

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NDA 083551 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 sixteen 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 083551
Tradename:PRIMIDONE
Applicant:Watson Labs
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 083551
Medical Subject Heading (MeSH) Categories for 083551
Suppliers and Packaging for NDA: 083551
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMIDONE primidone TABLET;ORAL 083551 ANDA Actavis Pharma, Inc. 0591-5321 N 0591-5321-01
PRIMIDONE primidone TABLET;ORAL 083551 ANDA Actavis Pharma, Inc. 0591-5321 N 0591-5321-10

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fuji
Mallinckrodt
McKesson
Cantor Fitzgerald
Julphar
Farmers Insurance
Daiichi Sankyo
Fish and Richardson

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