You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078476


✉ Email this page to a colleague

« Back to Dashboard


NDA 078476 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, and Wockhardt, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the FOSPHENYTOIN SODIUM profile page.

The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
Summary for 078476
Tradename:FOSPHENYTOIN SODIUM
Applicant:Amneal
Ingredient:fosphenytoin sodium
Patents:0
Suppliers and Packaging for NDA: 078476
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078476 ANDA Amneal Pharmaceuticals LLC 65162-998 65162-998-25 25 VIAL in 1 CARTON (65162-998-25) / 2 mL in 1 VIAL (65162-998-01)
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078476 ANDA Amneal Pharmaceuticals LLC 65162-999 65162-999-10 10 VIAL in 1 CARTON (65162-999-10) / 2 mL in 1 VIAL (65162-999-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG PHENYTOIN NA/ML
Approval Date:Mar 18, 2008TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.