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Pharmaceutical Business Intelligence

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Details for New Drug Application (NDA): 040521

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NDA 040521 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-one suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Suppliers and Packaging for NDA: 040521

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYTOIN
phenytoin
SUSPENSION;ORAL 040521 ANDA Atlantic Biologicals Corps 17856-4069 17856-4069-1 125 mL in 1 CUP (17856-4069-1)
PHENYTOIN
phenytoin
SUSPENSION;ORAL 040521 ANDA Atlantic Biologicals Corps 17856-4069 17856-4069-4 4.8 mL in 1 CUP (17856-4069-4)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Mar 8, 2004TE:ABRLD:No


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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.

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