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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Accenture
Farmers Insurance
Harvard Business School
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Boehringer Ingelheim
Baxter
Julphar
Daiichi Sankyo
Cerilliant

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040420

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NDA 040420 describes PHENYTOIN, which is a drug marketed by Actavis Mid Atlantic, Taro, Vistapharm, Wockhardt, Epic Pharma Llc, Mylan Pharms Inc, Aurobindo Pharma Ltd, Pharmeral, Watson Labs, Acella Pharms Llc, Fresenius Kabi Usa, Hospira, Luitpold, Marsam Pharms Llc, Smith And Nephew, Solopak, Warner Chilcott, and West-ward Pharms Int, and is included in twenty-four NDAs. It is available from thirteen suppliers. Additional details are available on the PHENYTOIN profile page.

The generic ingredient in PHENYTOIN is phenytoin sodium. There are nineteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for 040420

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 040420

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYTOIN phenytoin SUSPENSION;ORAL 040420 ANDA Atlantic Biologicals Corps 17856-0067 17856-0067-3 4 mL in 1 CUP (17856-0067-3)
PHENYTOIN phenytoin SUSPENSION;ORAL 040420 ANDA Physicians Total Care, Inc. 54868-2038 54868-2038-0 237 mL in 1 BOTTLE, GLASS (54868-2038-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Apr 19, 2002TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
Cerilliant
Farmers Insurance
Mallinckrodt
Fuji
Baxter
McKesson
Daiichi Sankyo
Cantor Fitzgerald
Healthtrust

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