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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Generated: June 20, 2018

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 Bio Ag, 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 twelve suppliers. Additional details are available on the PHENYTOIN profile page.

The generic ingredient in PHENYTOIN is phenytoin sodium. There are twenty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 200565
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 N 51672-4146-1
PHENYTOIN phenytoin TABLET, CHEWABLE;ORAL 200565 ANDA Taro Pharmaceuticals U.S.A., Inc 51672-4146 N 51672-4146-3

Profile for product number 001

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

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