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Details for New Drug Application (NDA): 040610

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NDA 040610 describes PHENYTOIN, which is a drug marketed by Vistapharm, Wockhardt, Taro, Corepharma, Mylan Pharms Inc, Actavis Mid Atlantic, Warner Chilcott, Marsam Pharms Llc, Fresenius Kabi Usa, Eurohlth Intl Sarl, Aurobindo Pharma Ltd, Smith And Nephew, Solopak, Hospira, Watson Labs, Pharmeral, X-gen Pharms, and Luitpold, and is included in twenty-four NDAs. It is available from fourteen 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 suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Suppliers and Packaging for NDA: 040610

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;ORAL 040610 ANDA Lehigh Valley Technologies, Inc. 64950-231 64950-231-24 237 mL in 1 BOTTLE, PLASTIC (64950-231-24)
SUSPENSION;ORAL 040610 ANDA VistaPharm Inc. 66689-775 66689-775-08 237 mL in 1 BOTTLE (66689-775-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Aug 18, 2005TE:ABRLD:No

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