BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
AstraZeneca
Deloitte
Dow
Fish and Richardson
Argus Health
Federal Trade Commission
Express Scripts
Colorcon

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200691

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NDA 200691 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 twelve 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-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 200691
Tradename:PHENYTOIN
Applicant:Mylan Pharms Inc
Ingredient:phenytoin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200691
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYTOIN phenytoin TABLET, CHEWABLE;ORAL 200691 ANDA Mylan Pharmaceuticals Inc. 0378-3850 0378-3850-05 500 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-05)
PHENYTOIN phenytoin TABLET, CHEWABLE;ORAL 200691 ANDA Mylan Pharmaceuticals Inc. 0378-3850 0378-3850-01 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength50MG
Approval Date:Dec 26, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
Accenture
Boehringer Ingelheim
Novartis
QuintilesIMS
Medtronic
Farmers Insurance
Deloitte
Daiichi Sankyo

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