Make Better Decisions

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ 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:

Daiichi Sankyo
Chinese Patent Office

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077989

« Back to Dashboard

NDA 077989 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Co, Apotex Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Mylan Labs Ltd, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Wockhardt, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the FOSPHENYTOIN SODIUM profile page.

The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
Summary for 077989
Applicant:West-ward Pharms Int
Ingredient:fosphenytoin sodium
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077989
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077989 ANDA West-Ward Pharmaceuticals Corp. 0641-6136 0641-6136-25 25 VIAL in 1 CARTON (0641-6136-25) > 2 mL in 1 VIAL (0641-6136-01)
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077989 ANDA West-Ward Pharmaceuticals Corp. 0641-6137 0641-6137-10 10 VIAL in 1 CARTON (0641-6137-10) > 10 mL in 1 VIAL (0641-6137-01)

Profile for product number 001

Approval Date:Aug 6, 2007TE:APRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
US Department of Justice

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.