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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040586

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NDA 040586 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. Eighteen suppliers are listed for this compound. Additional details are available on the primidone profile page.
Summary for 040586
Tradename:PRIMIDONE
Applicant:Vintage Pharms
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040586
Medical Subject Heading (MeSH) Categories for 040586
Suppliers and Packaging for NDA: 040586
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMIDONE primidone TABLET;ORAL 040586 ANDA Par Pharmaceutical 0603-5371 N 0603-5371-21
PRIMIDONE primidone TABLET;ORAL 040586 ANDA Par Pharmaceutical 0603-5371 N 0603-5371-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 24, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Feb 24, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Deloitte
Baxter
Federal Trade Commission
Cerilliant
Medtronic
Fuji
Merck
Healthtrust

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