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Generated: May 25, 2018

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 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 040866
Tradename:PRIMIDONE
Applicant:Amneal Pharm
Ingredient:primidone
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 N 0904-6207-60
PRIMIDONE primidone TABLET;ORAL 040866 ANDA AvKARE, Inc. 42291-509 N 42291-509-50

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Teva
Chinese Patent Office
Express Scripts
Boehringer Ingelheim
Chubb
Cantor Fitzgerald
Daiichi Sankyo
Colorcon

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