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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Fuji
Mallinckrodt
Chinese Patent Office
Argus Health
QuintilesIMS
AstraZeneca
Chubb
Cerilliant
Julphar
Novartis

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040866

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NDA 040866 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 040866

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 040866

Medical Subject Heading (MeSH) Categories for 040866

Suppliers and Packaging for NDA: 040866

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMIDONE primidone TABLET;ORAL 040866 ANDA Major Pharmaceuticals 0904-6207 0904-6207-60 100 TABLET in 1 BOTTLE (0904-6207-60)
PRIMIDONE primidone TABLET;ORAL 040866 ANDA AvKARE, Inc. 42291-509 42291-509-50 500 TABLET in 1 BOTTLE (42291-509-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 23, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Apr 23, 2008TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Medtronic
Johnson and Johnson
UBS
Mallinckrodt
Federal Trade Commission
Daiichi Sankyo
Chubb
Merck
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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