Make Better Decisions

  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Colorcon
Merck
Harvard Business School
Cantor Fitzgerald
US Department of Justice
Moodys
Fuji
Mallinckrodt

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083551

« Back to Dashboard

NDA 083551 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 083551
Tradename:PRIMIDONE
Applicant:Watson Labs
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 083551
Medical Subject Heading (MeSH) Categories for 083551
Suppliers and Packaging for NDA: 083551
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMIDONE primidone TABLET;ORAL 083551 ANDA Actavis Pharma, Inc. 0591-5321 0591-5321-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01)
PRIMIDONE primidone TABLET;ORAL 083551 ANDA Actavis Pharma, Inc. 0591-5321 0591-5321-10 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5321-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Cantor Fitzgerald
AstraZeneca
Chinese Patent Office
Argus Health
Fuji
Harvard Business School
Healthtrust

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.

botpot