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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Medtronic
Accenture
US Department of Justice
Baxter
Federal Trade Commission
Moodys
AstraZeneca
Citi

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040667

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NDA 040667 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 fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the primidone profile page.
Summary for 040667
Tradename:PRIMIDONE
Applicant:Hikma Intl Pharms
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040667
Medical Subject Heading (MeSH) Categories for 040667
Suppliers and Packaging for NDA: 040667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMIDONE primidone TABLET;ORAL 040667 ANDA West-ward Pharmaceutical Corp 0143-1482 N 0143-1482-05
PRIMIDONE primidone TABLET;ORAL 040667 ANDA West-ward Pharmaceutical Corp 0143-1482 N 0143-1482-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Jul 27, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 27, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Merck
US Army
Baxter
McKinsey
Medtronic
UBS
Cerilliant

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