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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Federal Trade Commission
US Department of Justice
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AstraZeneca
Farmers Insurance
Dow
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200565

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NDA 200565 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 200565

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

Suppliers and Packaging for NDA: 200565

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYTOIN phenytoin TABLET, CHEWABLE;ORAL 200565 ANDA Taro Pharmaceuticals U.S.A., Inc 51672-4146 51672-4146-3 1000 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-3)
PHENYTOIN phenytoin TABLET, CHEWABLE;ORAL 200565 ANDA Taro Pharmaceuticals U.S.A., Inc 51672-4146 51672-4146-6 30 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-6)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength50MG
Approval Date:Apr 17, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Chubb
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US Army

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