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Covington
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Federal Trade Commission
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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040626

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NDA 040626 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the primidone profile page.
Summary for 040626
Tradename:PRIMIDONE
Applicant:Anda Repository
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040626

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 29, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Sep 29, 2005TE:ABRLD:No

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