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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cerilliant
US Army
Cipla
McKinsey
Dow
Merck
McKesson
Daiichi Sankyo
Fuji

Generated: January 22, 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 eighteen 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. Nineteen 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 0143-1482-01 100 TABLET in 1 BOTTLE (0143-1482-01)
PRIMIDONE primidone TABLET;ORAL 040667 ANDA West-ward Pharmaceutical Corp 0143-1482 0143-1482-05 500 TABLET in 1 BOTTLE (0143-1482-05)

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 leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
US Army
Healthtrust
Novartis
Citi
UBS
Express Scripts
AstraZeneca

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